Freeze drying breast milk: what the evidence says

Q: Is freeze drying breast milk safe?

We are not going to answer that, and we would be the wrong source if we did. This is an appliance comparison site, the question is a clinical one, and it belongs with your doctor, your midwife or a lactation consultant. What this page does instead is set out what the published studies measured, what they found, how small they were, and what Australian authorities have and have not said, so that you can take an informed question to someone qualified to answer it.

Q: Has anyone studied home freeze dryers specifically?

No. That is the clearest gap in the literature. Every study we located used laboratory, pilot-scale, milk-bank or industrial equipment. None tested milk processed on a consumer machine of the kind this site otherwise writes about, so the published results cannot simply be assumed to describe what a domestic appliance produces.

Q: Does freeze drying kill bacteria in milk?

The published work indicates it does not. Freeze drying removes water; it is not a thermal kill step. One study excluded freeze drying on its own on microbiological grounds, and in the Australian research the pathogen reduction came from gamma irradiation applied after drying rather than from the drying itself. Milk that was unsafe before the process is not made safe by it.

Q: What do Australian regulators say?

Almost nothing, and that is itself worth knowing. Of the 8 Australian bodies we checked, 6 have published no position on freeze drying human milk at all. The TGA refers questions on human milk to state and territory health departments, and those departments have published nothing on drying or powdering either, so the referral leads nowhere. An absence of guidance is not the same thing as approval.

This page exists because people search for it and because the answers available are mostly written by companies selling the service. It sets out what the published research measured and found, and what Australian authorities have said. It does not tell you whether to do it.

What this page is not. It is not medical advice, it does not recommend for or against freeze drying breast milk, and it carries no affiliate link of any kind. Every statement about an effect below is attached to a named study with its sample size and its limitations. Where we have no evidence, the page says so rather than filling the space. If you are weighing this for your own child, the people to ask are your doctor, your midwife or a lactation consultant.

Literature and regulatory positions checked 10 September 2026

The gap that matters most

No published study we could find has tested milk processed on a consumer freeze dryer. Every one used laboratory, pilot-scale, milk-bank or industrial equipment. That matters more than it might sound on a site about home machines: the published results describe those processes, and cannot simply be assumed to describe what a domestic appliance produces in a kitchen.

1. NO STUDY HAS TESTED MILK PROCESSED ON A CONSUMER OR HOME FREEZE DRYER. Every peer-reviewed study located used a laboratory lyophiliser, a pilot or milk-bank unit, or an industrial commercial process. Alberta Health Services stated the same in 2021 ('none have studied the expression, transportation, freeze-drying, reconstitution, or storage and use of the product in a home or hospital setting') and nothing located since has changed that. This is the single clearest gap. 2. RESIDUAL MOISTURE ON HOME EQUIPMENT IS UNMEASURED. Laboratory studies that report residual moisture report figures such as below 2.2 percent (Blackshaw 2022) and 1.75 percent (Castro-Albarran 2016), and one 2026 study calculates monolayer moisture content for freeze-dried human milk at 0.0160 g water per g dry solids at 10C and 0.0035 g at 20C, with physical instability and lactose crystallisation appearing above a water activity of roughly 0.44 to 0.53 (Food Biophysics 2026). No published data establishes what residual moisture or water activity a home freeze dryer achieves with human milk, or how consistently. Castro-Albarran 2016 also documents that the settings which best preserve IgA are the settings that leave the most residual moisture, so the two goals are in tension. 3. MICROBIOLOGICAL SAFETY UNDER HOME CONDITIONS IS NOT ESTABLISHED. Freeze-drying is not a validated kill step; Jarzynka 2021 explicitly excluded freeze-drying alone as a preservation method on microbiological grounds. Every study used milk from screened milk-bank donors collected under milk-bank hygiene protocols. Reyes 2025 shows that milk expressed at home under ordinary consumer practices carries a materially different and higher bacterial load than milk expressed with sterilised equipment, and that only 22 percent of women washed their hands before pumping. No study has combined home-expressed milk, home drying, home storage and home reconstitution and measured what comes out. 4. LONG-TERM STORAGE STABILITY IS NOT ESTABLISHED. The longest storage period in any located human milk freeze-drying study is 6 months, and several key studies ran only 6 weeks. Commercial services in Australia claim a 3 year shelf life. There is no located published study supporting a 3 year figure for any measured component. Two studies report deterioration well inside 6 months: superoxide dismutase down about 27 percent at 6 weeks (Martysiak-Zurowska 2020), and growth-promoting bioactivity down to 72.8 percent versus 163.0 percent for frozen milk at 6 months (Kanaprach 2018). One study that reported good lipid stability to 180 days kept the lyophilised powder at -18C, that is, still frozen, which does not test pantry-temperature storage (Manin 2019). 5. NO CLINICAL OUTCOME DATA FOR HEALTHY TERM INFANTS FED FREEZE-DRIED MILK AT HOME. All clinical data concerns preterm or medically complex infants fed lyophilised donor milk as a fortifier in hospital under supervision, with a largest sample of 40 infants and a longest follow-up of 21 days. There are no growth, infection, allergy or development outcome data for healthy term infants fed reconstituted freeze-dried milk at home, and no trial comparing freeze-dried mother's own milk against frozen mother's own milk on any infant outcome. 6. NUTRITIONAL SUPERIORITY IS NOT ESTABLISHED AND HAS BEEN DIRECTLY CONTRADICTED. Alberta Health Services states verbatim that 'product claims of nutritional superiority of freeze-dried human milk, when compared with fresh or frozen human milk, are inaccurate and unfounded.' The claim made by one Australian service that freeze-dried milk 'retains all its nutrients' is not supported by the studies recording losses of vitamin C, total antioxidant capacity, IgA, arachidonic acid and docosahexaenoic acid. 7. RECONSTITUTION, OSMOLALITY AND DOSING ARE NOT ESTABLISHED FOR HOME USE. Osmolality was flagged by Alberta Health Services as one of three unassessed safety domains. Oliveira 2019 measured osmolality only in a milk-bank concentrate. No published work establishes safe water-to-powder ratios, safe use of the powder as a home fortifier, or what happens if a caregiver reconstitutes to a higher concentration than intended. 8. NO AUSTRALIAN REGULATORY OR PROFESSIONAL POSITION EXISTS. As at 12 September 2026 no Australian regulator (TGA, FSANZ, ACCC), no state or territory health department, no Australian professional college (RACGP) and no Australian consumer health body (ABA) has published any position, standard, guidance or warning on freeze drying breast milk. The absence of a rule is not an assessment that the practice is safe or unsafe; it is an absence of assessment.

What the research covers

We located 23 published items, spanning 2014 to 2026. They are small. 13 state a sample size and 10 do not state one at all, and among those that do, the sizes run from a single case report upward. Read the column of limitations as carefully as the column of findings.

WHAT EXISTS. A literature search on 12 September 2026 (PubMed, Crossref, Semantic Scholar, plus checks of cited reference lists) located a small body of peer-reviewed work on freeze-drying or lyophilising human milk: 23 records are held in this dataset, of which one is a scoping review that itself identified 48 articles after full-text review (Sproat 2024, Journal of Perinatology). The primary studies are almost all laboratory or human-milk-bank studies, and they are small. Where sample sizes are stated they run: 116 women (Cortez 2016), 125 samples from 65 donors (Salcedo 2015), 104 samples from 52 women in the home-hygiene study (Reyes 2025), 72 samples (Lozano 2014), 50 donors (Bomfim 2018), 10 pools from 40 specimens (Kanaprach 2018), 40 infants (LioNeo trial 2022), 32 plus 32 infants (Rochow 2025), 13 mothers (Vyarna 2026), 9 samples from 3 mothers (Hahn 2019 and Hahn 2020), and 1 infant (Ward 2026 case report). Several studies do not state a sample size at all. WHAT THE LABORATORY WORK REPORTS. Studies using laboratory lyophilisers generally report that macronutrients survive the process: protein, carbohydrate and total lipid content were preserved over up to 6 months (Cortez 2016, Lozano 2014, Manin 2019), human milk oligosaccharide patterns were unchanged (Hahn 2019), and 245 detected milk proteins showed no significant change by shotgun proteomics (Hahn 2020). Lactoferrin content, superoxide dismutase activity and fatty acid profile were unaffected immediately after drying, and lysozyme activity was slightly higher (Martysiak-Zurowska 2020). Freeze-drying alone did not reduce milk's own antibacterial growth-inhibition, whereas Holder pasteurisation did (Blackshaw 2021). WHAT THE SAME WORK REPORTS AS LOST OR CHANGED. Vitamin C fell significantly during storage of freeze-dried milk at both 4C and 40C, and antioxidant capacity fell at 40C (Lozano 2014). Total antioxidant capacity fell 22.1 percent on drying and superoxide dismutase activity fell about 27 percent over only 6 weeks of storage (Martysiak-Zurowska 2020). IgA is the immunoglobulin most sensitive to drying: freeze drying retained about 75 percent of IgA at lower plate temperatures and only about 55 percent at a 40C plate temperature, and the study documents a direct trade-off in which gentler drying preserves more immunoglobulin but leaves more residual moisture in the powder (Castro-Albarran 2016). Arachidonic acid fell from 0.35 to about 0.15 percent of total fatty acids and docosahexaenoic acid from 0.10 to about 0.06 percent in human milk lyophilisate concentrates (Bomfim 2018). Fat globule size is reduced, and enzymes, vitamin C and immunoglobulin are reduced, per the scoping review (Sproat 2024). In a direct head-to-head of storage methods, lyophilisation preserved fetal intestinal cell growth-promoting activity far worse than ordinary freezing over 6 months (72.8 percent versus 163.0 percent, p<0.005), and antimicrobial activity was lost at 6 months under both methods (Kanaprach 2018). A human milk concentrate made with lyophilisate lost energy, total lipids and copper over 3 and 6 months and the authors stated they do not recommend storing it (Oliveira 2019). MICROBIOLOGY. Freeze-drying is not a kill step. Jarzynka 2021 states that microbiological safety assessment excluded the possibility of using freeze-drying alone for human milk preservation, and positions freeze-drying as a storage method for milk already preserved by another process. In the Australian work from the University of Sydney and ANSTO, the pathogen reduction comparable to Holder pasteurisation came from 2 kGy gamma irradiation applied after freeze-drying, not from the drying itself (Blackshaw 2021, Blackshaw 2022). Every commercial and milk-bank process that claims microbiological control pasteurises before drying. Alberta Health Services states plainly that 'Freeze-drying does not remove bacteria or viruses present in human milk.' CLINICAL EVIDENCE. Clinical evidence in infants is confined to hospital use of lyophilised DONOR milk as a fortifier for preterm infants, under medical supervision: one phase I randomised double-blind trial in 40 very-low-birth-weight infants over 21 days that found no difference in safety and tolerability outcomes versus a cow's milk protein fortifier (LioNeo 2022); one non-randomised observational cohort of 32 versus 32 preterm infants over 30 weeks gestational age (Rochow 2025); and one industry-authored case report of a single infant using a mother's own milk freeze-dried commercially (Ward 2026, five of six authors employed by or consulting for the company whose process was used). The scoping review notes that serum electrolyte disturbances have been reported in preterm infants fed freeze-dried human milk. EQUIPMENT. Every study located used laboratory, pilot-scale, milk-bank or industrial equipment. No located study used a consumer or home freeze dryer. REGULATORY PICTURE IN AUSTRALIA. No Australian body has published a position on freeze drying breast milk. The TGA, FSANZ, the ACCC, NSW Health, Queensland Health, the Australian Breastfeeding Association and the RACGP were each checked and none has published guidance, a standard, a warning or a position on the practice. The TGA's only reference to breast milk is that no export permit is required and that people should ask their state or territory health department about handling and storage requirements, and no state or territory has published requirements that mention drying. Australian Red Cross Lifeblood, the main donor milk service, does not freeze dry: it Holder pasteurises and stores frozen with a 3 month expiry. The only health authority position located anywhere that addresses freeze-dried human milk directly is Canadian: Alberta Health Services Nutrition Services (November 2021) does not recommend its use in reconstituted form or as a fortifier in any setting, citing absent evidence on osmolar, microbial and nutritional safety.

The studies

The studiesSourced, dated, checkable
Study	Year	Sample	Measured	Reported	Limitations
Ward A, Reyes SM, Luck B, Serke L, Figard L, Kimball A (UChicago Medicine AdventHealth; Milkify Inc, Houston, Texas; Rev Bioscience; Rady Children's Hospital San Diego) American Journal of Perinatology Reports	2026	1	Single case report of a late preterm infant with complicated intestinal atresia and congenital shortened bowel, fortifying expressed mother's own milk with freeze-dried mother's own milk produced at a commercial facility using the SafeDry patented contact-free process, under medical supervision using targeted fortification.	The infant tolerated unfortified mother's own milk but developed severe fussiness, abdominal distention and increased stooling on hypoallergenic formula fortification. Those symptoms resolved within 24 hours of switching to freeze-dried mother's own milk fortification. Weight-for-age moved from the 24th to the 66th percentile over 86 days. Authors describe this as a potentially well tolerated strategy.	n=1 case report, the weakest study design for causal inference; no control and no blinding, and the reported outcome could reflect the change away from the formula fortifier rather than any property of freeze-drying. Industry conflict of interest declared: five of the six authors are employed by or consultants for Milkify, the commercial breast milk freeze-drying company whose patented process was used. Processing was at a commercial facility under a controlled proprietary process, not a consumer home freeze dryer. Hospital and post-discharge medical supervision throughout.
Alvarado Chavarria P, Shah FS, Hafeez A, Zafar S, Khan K (Vyarna OU, Estonia; National University of Sciences and Technology, Pakistan) Microbial Pathogenesis	2026	13 mothers	16S rRNA gene sequencing of bacterial composition in fresh, individually lyophilised, and mixed composite lyophilised breast milk samples from 13 mothers, for a commercial shelf-stable powder product.	The composite formulation showed greater bacterial richness and evenness by sequencing than any single source sample, with elevated relative abundance of Streptococcus salivarius and Lactococcus raffinolactis, reproducible across independently assembled mixes. The authors state explicitly that they do not claim viability or clinical outcomes.	Industry study: the first and last authors are affiliated with Vyarna OU, the company selling the product, the first author declares board membership and a pending patent. Only 13 mothers. 16S rRNA sequencing detects bacterial DNA and cannot distinguish live from dead organisms, and the authors themselves make no viability or clinical claim. Pooling milk from multiple unrelated donors into an infant product is the practice being described; no infant safety or outcome data are presented. Laboratory lyophilisation, not a consumer home freeze dryer.
Not fully recorded; published in Food Biophysics Food Biophysics	2026	not stated	Physicochemical stability of freeze-dried human milk powder: thermal transitions by differential scanning calorimetry, structure by X-ray diffraction and Fourier transform infrared spectroscopy, microstructure by scanning electron microscopy, and moisture sorption isotherms modelled with the Guggenheim-Anderson-de Boer (GAB) equation to build a state diagram.	Scanning electron microscopy showed a porous, heterogeneous microstructure in the dry powder. Monolayer moisture content was calculated at 0.0160 g water per g dry solids at 10C and 0.0035 g water per g dry solids at 20C. Beyond a water activity of approximately 0.44 to 0.53, sorption behaviour deviated from the expected trend, tentatively attributed to moisture-induced crystallisation of alpha-lactose monohydrate.	Materials-science study of powder physics, not a nutrition, immunology or safety study; it says nothing about whether the milk is safe or nutritious to feed. Sample number not stated in the sources accessed and full text not read. Laboratory freeze-drying and laboratory instrumentation. Recorded here because it is the only located work that quantifies the moisture thresholds at which freeze-dried human milk powder becomes physically unstable, which is directly relevant to whether any given drying process, laboratory or consumer, has removed enough water.
Rochow N, Weiss GA, Knab K, et al; Fusch C (Paracelsus Medical University Nuremberg, Germany; Rostock University Medical Center; McMaster University) Nutrients	2025	64 (32 exposed, 32 retrospectively matched comparison)	Prospective non-interventional observational cohort with a retrospectively matched comparison cohort. Preterm infants at or above 30 weeks gestational age received either freeze-dried high-temperature short-time pasteurised donor milk fortifier (1.6 to 4.8 g per 100 mL) or a bovine protein-based fortifier. Outcomes were feeding tolerance, safety parameters (blood glucose, triglycerides, urea) and anthropometry.	Feeding tolerance was reported as excellent across more than 3100 feedings. No necrotising enterocolitis, abdominal complications or serious adverse events occurred. Blood glucose, triglycerides and urea remained normal. Anthropometric and discharge outcomes did not differ significantly between cohorts. Authors noted the suboptimal protein-to-energy ratio may limit applicability for very low birth weight infants, and suggested use for preterm infants above 1500 g birth weight.	Observational, non-randomised, with a retrospectively matched comparison cohort, so confounding cannot be excluded. Small (32 per arm) and single centre. The product tested was a commercially freeze-dried, high-temperature short-time pasteurised donor milk fortifier produced under industrial conditions, not milk freeze-dried on a consumer home machine, and the milk was pasteurised before drying. Hospital setting with medical supervision. Authors declared no conflicts of interest.
Reyes SM, Allen DL, Williams JE, McGuire MA, McGuire MK, Rasmussen KM, Hay AG (Cornell University; Rev Bioscience LLC; University of Idaho) Journal of Translational Medicine	2025	104 paired milk samples from 52 healthy women	Secondary analysis comparing milk expressed with women's own personal pumps and their usual home hygiene practices against milk expressed with a hospital-grade pump and new commercially sterilised kits under study-controlled conditions. Microbiota characterised by aerobic culture and 16S rRNA gene sequencing.	Personal pump type had little impact. Pre-pumping handwashing, practised by only 22 percent of participants, was associated with lower bacterial counts. Milk expressed with home-sterilised kits had fewer total and gram-negative bacterial counts and lower relative abundance of Proteobacteria than milk expressed with handwashed kits. Authors concluded at-home hygiene practices, particularly kit cleaning method, substantially influence the milk microbiota.	This study is about home expression hygiene, not about freeze-drying; it is recorded here because it quantifies the microbial starting point of milk expressed at home, which differs from the milk-bank donor milk used in every freeze-drying study identified. Secondary analysis of an existing cohort. Healthy volunteer women, US. Authors declared no competing interests, although one author is affiliated with Rev Bioscience LLC, which has also worked with a commercial breast milk freeze-drying company.
Sproat TDR, Ghosh A, Alshaikh BN (University of Calgary; Royal Victoria Infirmary, Newcastle) Journal of Perinatology	2024	48 articles included after full-text review (scoping review, not a primary study)	Scoping review of the effect of freeze-drying on macronutrients, micronutrients, vitamins, bioactive components, microbes and antimicrobial factors in human milk, plus studies in which lyophilised human milk was fed to newborn infants.	Authors report that freeze-dried human milk reduces fat globule size and reduces the quantity of enzymes, vitamin C and immunoglobulin. They report that common serum electrolyte disturbances have been reported when preterm infants are fed freeze-dried human milk, while noting it appears a promising method to avoid exposing preterm infants to cows' milk. Conclusion states that due to limited data, further studies exploring safety and efficacy in preterm infants are needed.	Scoping review, not a systematic review or meta-analysis; no pooled quantitative synthesis and no formal risk-of-bias assessment. The 48 included articles are heterogeneous in method and milk source. All included work concerns laboratory or milk-bank lyophilisation equipment and clinical use in neonatal units; the review does not address consumer or home freeze dryers. Findings apply to preterm infants in hospital, not to healthy term infants at home. Funding source not stated in the abstract.
Davila-Caraballo GJ, Serrato-Marquez E, Grimaldo-Rivas MD, Chuck-Hernandez CE, Vega-Cantu YI, Ortega-Alonzo SE, Coronado-Cerda E, Urrutia-Baca VH (Mexico) Journal of Food Composition and Analysis	2024	not stated	Carbohydrate profile, protein quantity and electrophoretic characteristics, cytokines, oligosaccharides, secretory immunoglobulin A, pH, density and moisture in human breast milk preserved by freezing at -20C, ultra-cold freezing at -80C, and freeze-drying.	No differences were detected between preservation methods in pH, density, moisture, total crude protein, cytokines, four oligosaccharides or secretory immunoglobulin A. Electrophoretic patterns included a band between 75 and 100 kDa attributed to lactoferrin (80 kDa), identifiable across all preservation conditions.	Sample number not stated in the sources accessed; the full text is paywalled and could not be read directly, so this record is based on the published abstract and indexing. Laboratory freeze-drying, not a consumer home freeze dryer. IMPORTANT: a Corrigendum to this article was published in the Journal of Food Composition and Analysis in 2026 (doi 10.1016/j.jfca.2025.108758); the content of that correction could not be retrieved and should be checked before this study's numbers are relied on. Comparison is against frozen storage, not against fresh milk. No microbiological safety or infant outcome endpoints.
Blackshaw K, Wu J, Proschogo N, Davies J, Oldfield D, Schindeler A, Banati RB, Dehghani F, Valtchev P (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia) Food Chemistry	2022	not stated	Volatile profile by solid-phase microextraction GC-MS and protein profile by SDS and native PAGE gel electrophoresis in donor human milk that was Holder pasteurised, freeze-dried, and freeze-dried then treated with 2 kGy in-package gamma irradiation. Residual moisture of the freeze-dried product was measured.	Overall changes in volatile and protein profiles after Holder pasteurisation and after freeze-drying were reported as negligible compared with the natural variation between donor milk samples. Freeze-dried samples reached moisture below 2.2 percent. Freeze-dried samples given 2 kGy gamma irradiation showed no significant lipid oxidation end-products and no variation in protein profile. Authors proposed freeze-drying followed by in-package gamma irradiation as a route to ambient-temperature storage of donor milk.	Sample number not stated in the abstract. Laboratory and pilot-scale freeze-drying, not a consumer home freeze dryer. The proposed process includes 2 kGy gamma irradiation, which is not available outside an irradiation facility, so the safety result does not transfer to freeze-drying alone at home. Analytical endpoints are volatile and protein profiles and lipid oxidation, not a full immunological or clinical outcome set. Australian authorship includes ANSTO and the Mothers Milk Bank Charity; funding arrangements not stated in the abstract.
Nogueira-Pileggi V, Achcar MC, Carmona F, et al; Camelo Junior JS (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) British Journal of Nutrition	2022	40	Phase I double-blind randomised controlled trial in 40 very-low-birth-weight infants (birth weight 750 to 1500 g) receiving donor human milk, randomised to fortification with lyophilised human milk (LioNeo) or a commercial cows' milk protein additive, followed 21 days. Primary outcomes were necrotising enterocolitis, late-onset sepsis, death, gastrointestinal bleeding or perforation, diarrhoea, regurgitation, vomiting and abdominal distension.	No differences between groups on the primary outcomes in regression models. Diarrhoea, gastrointestinal perforation, necrotising enterocolitis and late-onset sepsis were absent in the LioNeo group, with one late-onset sepsis and one necrotising enterocolitis case in the comparison group. Authors concluded lyophilisation of donor human milk was safe and tolerable in haemodynamically stable very-low-birth-weight infants.	Phase I safety and tolerability trial with only 40 infants, and only 21 days of follow-up; it is not powered to detect differences in rare outcomes such as necrotising enterocolitis or sepsis, and the authors frame it as safety and tolerability rather than efficacy. Milk was banked donor milk pooled and lyophilised under human milk bank and laboratory conditions, not a consumer home freeze dryer. Hospital NICU setting with medical supervision. Single centre, Brazil. This is the most substantial clinical trial identified and its sample size is 40.
Blackshaw K, Wu J, Valtchev P, Lau E, Banati RB, Dehghani F, Schindeler A (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia) Foods	2021	not stated	Bacterial growth inhibition assays on donor human milk that was raw, Holder pasteurised, freeze-dried, or freeze-dried then gamma-irradiated at 2 to 50 kGy, using inoculants of Staphylococcus aureus, Salmonella typhimurium and Escherichia coli at 10^6 cfu/mL.	Freeze-drying followed by 2 kGy gamma irradiation was as efficient as Holder pasteurisation at reducing S. aureus and S. typhimurium inoculants. Human milk naturally inhibited growth of all three inoculants. Freeze-drying alone did not significantly reduce that natural growth inhibition, whereas Holder pasteurisation significantly reduced the milk's natural antimicrobial effect against S. aureus after 6 h (-19.8 percent, p=0.01).	Sample number not stated in the abstract. Laboratory freeze-drying, not a consumer home freeze dryer. The bacterial kill step in this work is the gamma irradiation, not the freeze-drying: the paper does not establish that freeze-drying alone makes milk microbiologically safe. In vitro inoculation assay only, no infant outcomes. Authors declared no conflict of interest.
Jarzynka S, Strom K, Barbarska O, Pawlikowska E, Minkiewicz-Zochniak A, Rosiak E, Oledzka G, Wesolowska A (Medical University of Warsaw and Regional Human Milk Bank, Holy Family Hospital, Poland) International Journal of Environmental Research and Public Health	2021	not stated	Concentration of bioactive components (insulin, adiponectin, leptin, pancreatic lipase activity, hepatocyte growth factor) and microbiological safety in raw, Holder pasteurised, high-pressure processed, and lyophilised donor human milk.	The combination of high-pressure processing plus freeze-drying best preserved nutritional and bioactive value while meeting microbiological safety criteria. The authors state explicitly that microbiological safety assessment excluded the possibility of using freeze-drying alone to preserve human milk samples, and that freeze-drying is suitable as a long-term storage method for milk already preserved by another process.	Sample number not stated in the abstract. Laboratory and milk-bank equipment including a high-pressure processing rig, not a consumer home freeze dryer. The favourable result is for the combined high-pressure plus freeze-drying process, not freeze-drying alone. A correction to this article was published in 2024 (Int J Environ Res Public Health 2024;21(7):822). Authors declared no conflict of interest.
Hahn WH, Bae SP, Song S, Park S, Lee J, Seo JB, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea) Journal of Maternal-Fetal and Neonatal Medicine	2020	9 milk samples from 3 mothers (collected at 15 and 60 days of lactation)	Shotgun proteomic analysis by mass spectrometry of human milk before and after freeze-drying, with functional bioinformatic grouping of detected proteins.	245 proteins were detected. Protein expression was not significantly affected by lactation period or by freeze-drying (p>.050), and functional analysis showed no significant difference. The authors themselves state that the number of samples was quite small to provide strong evidence, and that evaluation of safe storage length with respect to infectious agents and composition change after freeze-drying is warranted.	Very small sample: 9 samples from only 3 mothers, and the authors explicitly flag this as too small for strong evidence. Laboratory lyophilisation, not a consumer home freeze dryer. Proteomic detection measures whether proteins are present, not whether bioactive proteins retain function. No microbiological safety endpoint and no storage-duration testing. Funding source not stated in the abstract.
Martysiak-Zurowska D, Rozek P, Puta M (Gdansk University of Technology, Poland) Drying Technology	2020	not stated	Lysozyme activity, lactoferrin content, superoxide dismutase (SOD) activity, total antioxidant capacity (TAC) and fatty acid profile in pooled human milk that was freeze-dried and then stored for 6 weeks at 5C and at 25C. Water removal was also quantified.	Freeze-drying decreased water content by 86.5 percent and the lyophilisate was readily soluble. Freeze-drying did not affect SOD activity, fatty acid profile or lactoferrin content, decreased total antioxidant capacity by 22.1 percent, and produced a minor apparent increase in lysozyme activity of about 9.8 percent. Over 6 weeks of storage, TAC, lactoferrin, fatty acids and lysozyme were stable, but SOD activity fell by about 27 percent relative to the level immediately after lyophilisation.	Milk was pooled, so individual variation is lost and no per-donor sample size is reported. Laboratory lyophilisation, not a consumer home freeze dryer. Storage window only 6 weeks, which is far shorter than the multi-year shelf life claimed by commercial services. Water content was reduced by 86.5 percent, which is a relative reduction and not the same as a stated residual moisture figure. No microbiological safety endpoint and no infant outcomes. Funding source not stated in the abstract.
Hahn WH, Kim J, Song S, Park S, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea) Journal of Maternal-Fetal and Neonatal Medicine	2019	9 milk samples from 3 mothers	Human milk oligosaccharide (HMO) profiles by MALDI TOF/TOF mass spectrometry, before and after Holder pasteurisation and freeze-drying.	HMO patterns differed significantly between mothers but were not affected by lactation period within the first 3 weeks. Correlation analysis found neither pasteurisation nor freeze-drying altered HMO patterns (r2 0.989 to 0.999, p<.001). Authors state that storage length without HMO composition change after freeze-drying still needs evaluation.	Very small sample: 9 samples from only 3 mothers. Laboratory lyophilisation, not a consumer home freeze dryer. Single endpoint (HMO profile) measured immediately after processing, with no storage-duration testing, no microbiological endpoint and no infant outcomes. Milk was not pooled across a donor population, so between-mother variation dominates. Funding source not stated in the abstract.
Oliveira MM, Aragon DC, Bomfim VS, et al; Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) PLoS One	2019	not stated	Osmolality (freezing point osmometry) and macronutrient (MIRIS human milk analyser) and micronutrient (flame atomic absorption spectrophotometry and automated colorimetry) concentrations in baseline donor human milk and in human milk concentrates made with human milk lyophilisate, measured immediately and after 3 and 6 months of frozen storage.	Adding lyophilisate significantly increased energy, carbohydrate and total lipid concentration relative to baseline milk. Over storage, calcium and phosphorus rose and energy, total lipids and copper fell at 3 months; at 6 months calcium, magnesium, potassium, zinc and phosphorus rose while energy, total lipids and copper fell. The authors concluded the immediate concentrate is usable but that the partial stability of the concentrates over storage means they do not recommend storage.	Preclinical laboratory study, not an infant feeding study; number of donors or samples not stated in the abstract. Milk-bank and laboratory lyophilisation, not a consumer home freeze dryer. The explicit negative finding is instability over 3 and 6 months of storage, with the authors advising against storing the concentrate. No immunological or microbiological endpoints. Authors declared no competing interests.
Manin LP, Rydlewski AA, Galuch MB, Pizzo JS, Zappielo CD, Senes CER, Santos OO, Visentainer JV (Universidade Estadual de Maringa, Brazil) Journal of the Brazilian Chemical Society	2019	not stated	Acidity (Dornic degrees), lipid content, fatty acid composition (GC-FID) and major triacylglycerol profile (ESI-MS) of lyophilised, vacuum-packed colostrum, transitional and mature human milk at 1, 30, 60, 90, 120, 150 and 180 days of storage at -18C.	No significant differences in acidity, lipid content or fatty acid composition were observed across the 180-day period, and the relative percentage of major triacylglycerols was not altered. Authors concluded lyophilisation is a good alternative for human milk banks.	Sample number not stated in the abstract. Milk was pasteurised before lyophilisation, so this is not raw milk. Laboratory lyophilisation with vacuum packing, not a consumer home freeze dryer. Critically, the lyophilised product was stored at -18C, that is, still frozen, so this study does not test ambient or pantry-temperature shelf stability, which is the claim made for consumer freeze-dried milk. Lipid endpoints only, no immunological or microbiological outcomes. Funding source not stated in the abstract.
Bomfim VS, Jordao AA Jr, Alves LG, Martinez FE, Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) PLoS One	2018	50 donors	Total lipid content (MIRIS human milk analyser) and fatty acid profile (gas chromatography, CG-FID) in baseline donor human milk and in concentrates made with human milk lyophilisate, immediately and after 3 and 6 months of storage.	Lipid concentration was higher in the immediate concentrate than baseline milk. Palmitic acid changed significantly across conditions (p<0.01). Arachidonic acid fell from 0.35 percent of total fatty acids at baseline to 0.16 percent in the immediate concentrate and 0.13 to 0.15 percent on storage (p<0.01), and docosahexaenoic acid fell from 0.10 percent to 0.06 percent and 0.05 to 0.06 percent (p<0.01). Oleic, linoleic and alpha-linolenic acids did not change significantly. There were no significant changes in the lipid profile during storage and no evidence of peroxidation. Authors concluded further clinical studies are required to evaluate safety and efficacy.	Preclinical laboratory study with no infant outcomes. Milk-bank and laboratory lyophilisation, not a consumer home freeze dryer; donor milk from a hospital human milk bank. The significant falls in arachidonic acid and docosahexaenoic acid are measured losses of long-chain polyunsaturated fatty acids relative to baseline milk. Authors declared no competing interests.
Kanaprach P, Pongsakul N, Apiwattanakul N, Muanprasat C, Supapannachart S, Nuntnarumit P, Chutipongtanate S (Mahidol University, Ramathibodi Hospital, Thailand) Breastfeeding Medicine	2018	10 pools produced from 40 independent donor milk specimens	Fetal intestinal cell growth assay and antimicrobial activity against Escherichia coli in donor milk after bacterial elimination (Holder pasteurisation or cold-sterilisation microfiltration) and after storage by freezing at -20C or by lyophilisation, at 0, 3 and 6 months.	Raw donor milk showed 193.1 +/- 12.3 percent fetal intestinal cell growth and 42.4 +/- 11.8 percent antimicrobial activity against E. coli. Over 6 months of storage, freezing preserved growth-promoting activity substantially better than lyophilisation (163.0 +/- 9.4 percent versus 72.8 +/- 6.2 percent, p<0.005). Antimicrobial activity was lost at 6 months regardless of storage method. Authors concluded donor milk should be used within 3 months after preparative processes.	Milk was pooled: 10 pools from 40 specimens, so individual variation is not captured. Laboratory lyophilisation, not a consumer home freeze dryer. All storage arms were pasteurised or microfiltered first, so the lyophilisation arm is not raw milk. In vitro cell and antimicrobial assays, not infant outcomes. This is a directly negative finding for lyophilised storage at 6 months and is the clearest counterweight to the studies reporting preservation.
Castro Albarran J, Navarro Hernandez RE, Solis Pacheco JR, Salazar Quinones IC, Macias Lopez GG, Barrera de Leon JC, Aguilar Uscanga BR (Universidad de Guadalajara, Mexico) Nutricion Hospitalaria	2017	not stated	Total protein (Lowry method) and concentrations of immunoglobulins A, G and M and complement C3 (nephelometry) in mature human milk pasteurised by three regimes (62.5C/30 min, 72C/15 min, 85C/5 min) and then freeze-dried in 30 mL volumes over 36 hours.	Pasteurisation at 62.5C gave the highest protein and immunoglobulin retention overall, but pasteurisation at 72C before freeze-drying showed better immunoglobulin retention. Authors concluded freeze-drying of pasteurised mature milk is a suitable conservation method for hospital milk banks.	Descriptive study; sample number not stated in the abstract. Every arm was pasteurised before freeze-drying, so the study does not isolate the effect of freeze-drying alone and does not describe unpasteurised milk. Laboratory lyophiliser, not a consumer home freeze dryer. No control comparison against fresh unprocessed milk reported in the abstract, and no microbiological or clinical endpoints. Funding source not stated in the abstract.
Cortez MV, Soria EA (Universidad Nacional de Cordoba / CONICET, Argentina) Breastfeeding Medicine	2016	116	Protein, glucose, triglycerides, polyphenols and oxidative markers (nitrites, superoxide anion, hydroperoxides, lipoperoxides, gamma-glutamyl transpeptidase) in milk from 116 healthy women, compared across three treatments: frozen and held 6 months at -80C (control); freeze-dried 24 h at <=-70C and <=1.33 Pa then held 6 months at 4C; and freeze-dried then held 6 months at -80C.	Glucose decreased after freezing alone (p<0.05). All measured variables were conserved by freeze-drying, and the freeze-drying plus freezing combination did not improve on freeze-drying alone. Authors concluded freeze-drying achieved suitable conservation of nutritional properties, polyphenol-related functionality and oxidative integrity over the 6-month window tested.	Laboratory lyophiliser operating at <=-70C and <=1.33 Pa (about 0.013 mbar); this is not the same process as a consumer home freeze dryer and the results cannot be assumed to transfer. Single centre, Argentina. Outcome set is nutrient and oxidative chemistry only: no immunoglobulin, lactoferrin, lysozyme or microbiological safety endpoints. Storage window limited to 6 months. Residual moisture of the dried product not reported in the abstract. Funding source not stated in the abstract.
Castro-Albarran J, Aguilar-Uscanga BR, Calon F, St-Amour I, Solis-Pacheco J, Saucier L, Ratti C (Universidad de Guadalajara, Mexico; Universite Laval, Canada) Drying Technology	2016	not stated	Retention of immunoglobulins IgA, IgG and IgM in human milk powder produced by spray drying and by freeze drying at different heating plate temperatures, with residual humidity of the powders recorded.	Spray drying produced powders at about 2 percent humidity with retention above 88 percent for IgG and about 70 percent for IgM, but only about 38 percent of IgA remained. For freeze drying, the highest heating plate temperature tested (40C) reduced IgA to about 55 percent in powder with 1.75 percent residual humidity, while lower plate temperatures gave higher retention, about 75 percent for IgA and about 80 percent for IgG and IgM, with correspondingly higher residual moisture. Authors concluded IgA is the immunoglobulin most sensitive to drying, and that freeze drying at a 30C plate temperature was the best compromise.	Sample number not stated. Laboratory spray dryer and laboratory freeze dryer, not a consumer home freeze dryer, and the key variable driving the result (heating plate temperature) is a parameter a consumer machine does not expose or control in the same way. Note the direct trade-off the study documents: lower plate temperature preserved more immunoglobulin but left more residual moisture in the powder, and residual moisture is itself a storage-stability and microbiological risk factor. Even at best, IgA retention was about 75 percent, that is, a measurable loss. Published in a drying engineering journal; funding source not stated in the sources accessed.
Salcedo J, Gormaz M, Lopez-Mendoza MC, Nogarotto E, Silvestre D (University Cardenal Herrera-CEU and Hospital La Fe Human Milk Bank, Valencia, Spain) Journal of Pediatric Gastroenterology and Nutrition	2015	125 milk samples from 65 healthy donors	Microbiological content, bactericidal activity, sialic acid and ganglioside content, and protein, fat and lactose concentrations, compared across lyophilisation and freezing at -20C and at -80C.	Lyophilisation and storage at -80C significantly reduced counts of mesophilic aerobic microorganisms and Staphylococcus epidermidis compared with storage at -20C. Bactericidal activity was not significantly changed by lyophilisation compared with freezing at either temperature. Bactericidal activity was not correlated with fat, protein or lactose but was correlated with ganglioside content, and was significantly greater in mature milk and in milk from term deliveries.	Laboratory or milk-bank lyophiliser, not a consumer home freeze dryer. Donor milk from a hospital milk bank collected under milk-bank hygiene protocols, so the microbiological starting point is not comparable to home expression and handling. Reduction in bacterial counts is relative to frozen storage, not evidence of a validated kill step. No infant clinical outcomes. Funding source not stated in the abstract.
Lozano B, Castellote AI, Montes R, Lopez-Sabater MC (University of Barcelona, Spain) International Journal of Food Sciences and Nutrition	2014	72	Vitamin C (ascorbic acid and total), tocopherols, antioxidant capacity and fatty acid composition in 72 samples of freeze-dried human milk stored for up to 3 months at either 4C or 40C.	Ascorbic acid and total vitamin C concentrations decreased significantly at both storage temperatures. Antioxidant capacity decreased only at 40C. Fatty acid composition and gamma-tocopherol and delta-tocopherol content remained unaltered. Authors reported stability after storage of freeze-dried milk was higher than previously reported for frozen or fresh milk.	Laboratory lyophilisation, not a consumer home freeze dryer. Maximum storage window tested was 3 months, so longer-term stability is not addressed. Vitamin C loss is a measured negative finding. No immunological or microbiological endpoints. Residual moisture not reported in the abstract. Whether samples were pooled is not stated in the abstract. Funding source not stated in the abstract.

The studiesSourced, dated, checkable

Ward A, Reyes SM, Luck B, Serke L, Figard L, Kimball A (UChicago Medicine AdventHealth; Milkify Inc, Houston, Texas; Rev Bioscience; Rady Children's Hospital San Diego)
American Journal of Perinatology Reports

Year: 2026
Sample: 1
Measured: Single case report of a late preterm infant with complicated intestinal atresia and congenital shortened bowel, fortifying expressed mother's own milk with freeze-dried mother's own milk produced at a commercial facility using the SafeDry patented contact-free process, under medical supervision using targeted fortification.
Reported: The infant tolerated unfortified mother's own milk but developed severe fussiness, abdominal distention and increased stooling on hypoallergenic formula fortification. Those symptoms resolved within 24 hours of switching to freeze-dried mother's own milk fortification. Weight-for-age moved from the 24th to the 66th percentile over 86 days. Authors describe this as a potentially well tolerated strategy.
Limitations: n=1 case report, the weakest study design for causal inference; no control and no blinding, and the reported outcome could reflect the change away from the formula fortifier rather than any property of freeze-drying. Industry conflict of interest declared: five of the six authors are employed by or consultants for Milkify, the commercial breast milk freeze-drying company whose patented process was used. Processing was at a commercial facility under a controlled proprietary process, not a consumer home freeze dryer. Hospital and post-discharge medical supervision throughout.

Alvarado Chavarria P, Shah FS, Hafeez A, Zafar S, Khan K (Vyarna OU, Estonia; National University of Sciences and Technology, Pakistan)
Microbial Pathogenesis

Year: 2026
Sample: 13 mothers
Measured: 16S rRNA gene sequencing of bacterial composition in fresh, individually lyophilised, and mixed composite lyophilised breast milk samples from 13 mothers, for a commercial shelf-stable powder product.
Reported: The composite formulation showed greater bacterial richness and evenness by sequencing than any single source sample, with elevated relative abundance of Streptococcus salivarius and Lactococcus raffinolactis, reproducible across independently assembled mixes. The authors state explicitly that they do not claim viability or clinical outcomes.
Limitations: Industry study: the first and last authors are affiliated with Vyarna OU, the company selling the product, the first author declares board membership and a pending patent. Only 13 mothers. 16S rRNA sequencing detects bacterial DNA and cannot distinguish live from dead organisms, and the authors themselves make no viability or clinical claim. Pooling milk from multiple unrelated donors into an infant product is the practice being described; no infant safety or outcome data are presented. Laboratory lyophilisation, not a consumer home freeze dryer.

Not fully recorded; published in Food Biophysics
Food Biophysics

Year: 2026
Sample: not stated
Measured: Physicochemical stability of freeze-dried human milk powder: thermal transitions by differential scanning calorimetry, structure by X-ray diffraction and Fourier transform infrared spectroscopy, microstructure by scanning electron microscopy, and moisture sorption isotherms modelled with the Guggenheim-Anderson-de Boer (GAB) equation to build a state diagram.
Reported: Scanning electron microscopy showed a porous, heterogeneous microstructure in the dry powder. Monolayer moisture content was calculated at 0.0160 g water per g dry solids at 10C and 0.0035 g water per g dry solids at 20C. Beyond a water activity of approximately 0.44 to 0.53, sorption behaviour deviated from the expected trend, tentatively attributed to moisture-induced crystallisation of alpha-lactose monohydrate.
Limitations: Materials-science study of powder physics, not a nutrition, immunology or safety study; it says nothing about whether the milk is safe or nutritious to feed. Sample number not stated in the sources accessed and full text not read. Laboratory freeze-drying and laboratory instrumentation. Recorded here because it is the only located work that quantifies the moisture thresholds at which freeze-dried human milk powder becomes physically unstable, which is directly relevant to whether any given drying process, laboratory or consumer, has removed enough water.

Rochow N, Weiss GA, Knab K, et al; Fusch C (Paracelsus Medical University Nuremberg, Germany; Rostock University Medical Center; McMaster University)
Nutrients

Year: 2025
Sample: 64 (32 exposed, 32 retrospectively matched comparison)
Measured: Prospective non-interventional observational cohort with a retrospectively matched comparison cohort. Preterm infants at or above 30 weeks gestational age received either freeze-dried high-temperature short-time pasteurised donor milk fortifier (1.6 to 4.8 g per 100 mL) or a bovine protein-based fortifier. Outcomes were feeding tolerance, safety parameters (blood glucose, triglycerides, urea) and anthropometry.
Reported: Feeding tolerance was reported as excellent across more than 3100 feedings. No necrotising enterocolitis, abdominal complications or serious adverse events occurred. Blood glucose, triglycerides and urea remained normal. Anthropometric and discharge outcomes did not differ significantly between cohorts. Authors noted the suboptimal protein-to-energy ratio may limit applicability for very low birth weight infants, and suggested use for preterm infants above 1500 g birth weight.
Limitations: Observational, non-randomised, with a retrospectively matched comparison cohort, so confounding cannot be excluded. Small (32 per arm) and single centre. The product tested was a commercially freeze-dried, high-temperature short-time pasteurised donor milk fortifier produced under industrial conditions, not milk freeze-dried on a consumer home machine, and the milk was pasteurised before drying. Hospital setting with medical supervision. Authors declared no conflicts of interest.

Reyes SM, Allen DL, Williams JE, McGuire MA, McGuire MK, Rasmussen KM, Hay AG (Cornell University; Rev Bioscience LLC; University of Idaho)
Journal of Translational Medicine

Year: 2025
Sample: 104 paired milk samples from 52 healthy women
Measured: Secondary analysis comparing milk expressed with women's own personal pumps and their usual home hygiene practices against milk expressed with a hospital-grade pump and new commercially sterilised kits under study-controlled conditions. Microbiota characterised by aerobic culture and 16S rRNA gene sequencing.
Reported: Personal pump type had little impact. Pre-pumping handwashing, practised by only 22 percent of participants, was associated with lower bacterial counts. Milk expressed with home-sterilised kits had fewer total and gram-negative bacterial counts and lower relative abundance of Proteobacteria than milk expressed with handwashed kits. Authors concluded at-home hygiene practices, particularly kit cleaning method, substantially influence the milk microbiota.
Limitations: This study is about home expression hygiene, not about freeze-drying; it is recorded here because it quantifies the microbial starting point of milk expressed at home, which differs from the milk-bank donor milk used in every freeze-drying study identified. Secondary analysis of an existing cohort. Healthy volunteer women, US. Authors declared no competing interests, although one author is affiliated with Rev Bioscience LLC, which has also worked with a commercial breast milk freeze-drying company.

Sproat TDR, Ghosh A, Alshaikh BN (University of Calgary; Royal Victoria Infirmary, Newcastle)
Journal of Perinatology

Year: 2024
Sample: 48 articles included after full-text review (scoping review, not a primary study)
Measured: Scoping review of the effect of freeze-drying on macronutrients, micronutrients, vitamins, bioactive components, microbes and antimicrobial factors in human milk, plus studies in which lyophilised human milk was fed to newborn infants.
Reported: Authors report that freeze-dried human milk reduces fat globule size and reduces the quantity of enzymes, vitamin C and immunoglobulin. They report that common serum electrolyte disturbances have been reported when preterm infants are fed freeze-dried human milk, while noting it appears a promising method to avoid exposing preterm infants to cows' milk. Conclusion states that due to limited data, further studies exploring safety and efficacy in preterm infants are needed.
Limitations: Scoping review, not a systematic review or meta-analysis; no pooled quantitative synthesis and no formal risk-of-bias assessment. The 48 included articles are heterogeneous in method and milk source. All included work concerns laboratory or milk-bank lyophilisation equipment and clinical use in neonatal units; the review does not address consumer or home freeze dryers. Findings apply to preterm infants in hospital, not to healthy term infants at home. Funding source not stated in the abstract.

Davila-Caraballo GJ, Serrato-Marquez E, Grimaldo-Rivas MD, Chuck-Hernandez CE, Vega-Cantu YI, Ortega-Alonzo SE, Coronado-Cerda E, Urrutia-Baca VH (Mexico)
Journal of Food Composition and Analysis

Year: 2024
Sample: not stated
Measured: Carbohydrate profile, protein quantity and electrophoretic characteristics, cytokines, oligosaccharides, secretory immunoglobulin A, pH, density and moisture in human breast milk preserved by freezing at -20C, ultra-cold freezing at -80C, and freeze-drying.
Reported: No differences were detected between preservation methods in pH, density, moisture, total crude protein, cytokines, four oligosaccharides or secretory immunoglobulin A. Electrophoretic patterns included a band between 75 and 100 kDa attributed to lactoferrin (80 kDa), identifiable across all preservation conditions.
Limitations: Sample number not stated in the sources accessed; the full text is paywalled and could not be read directly, so this record is based on the published abstract and indexing. Laboratory freeze-drying, not a consumer home freeze dryer. IMPORTANT: a Corrigendum to this article was published in the Journal of Food Composition and Analysis in 2026 (doi 10.1016/j.jfca.2025.108758); the content of that correction could not be retrieved and should be checked before this study's numbers are relied on. Comparison is against frozen storage, not against fresh milk. No microbiological safety or infant outcome endpoints.

Blackshaw K, Wu J, Proschogo N, Davies J, Oldfield D, Schindeler A, Banati RB, Dehghani F, Valtchev P (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia)
Food Chemistry

Year: 2022
Sample: not stated
Measured: Volatile profile by solid-phase microextraction GC-MS and protein profile by SDS and native PAGE gel electrophoresis in donor human milk that was Holder pasteurised, freeze-dried, and freeze-dried then treated with 2 kGy in-package gamma irradiation. Residual moisture of the freeze-dried product was measured.
Reported: Overall changes in volatile and protein profiles after Holder pasteurisation and after freeze-drying were reported as negligible compared with the natural variation between donor milk samples. Freeze-dried samples reached moisture below 2.2 percent. Freeze-dried samples given 2 kGy gamma irradiation showed no significant lipid oxidation end-products and no variation in protein profile. Authors proposed freeze-drying followed by in-package gamma irradiation as a route to ambient-temperature storage of donor milk.
Limitations: Sample number not stated in the abstract. Laboratory and pilot-scale freeze-drying, not a consumer home freeze dryer. The proposed process includes 2 kGy gamma irradiation, which is not available outside an irradiation facility, so the safety result does not transfer to freeze-drying alone at home. Analytical endpoints are volatile and protein profiles and lipid oxidation, not a full immunological or clinical outcome set. Australian authorship includes ANSTO and the Mothers Milk Bank Charity; funding arrangements not stated in the abstract.

Nogueira-Pileggi V, Achcar MC, Carmona F, et al; Camelo Junior JS (Ribeirao Preto Medical School, University of Sao Paulo, Brazil)
British Journal of Nutrition

Year: 2022
Sample: 40
Measured: Phase I double-blind randomised controlled trial in 40 very-low-birth-weight infants (birth weight 750 to 1500 g) receiving donor human milk, randomised to fortification with lyophilised human milk (LioNeo) or a commercial cows' milk protein additive, followed 21 days. Primary outcomes were necrotising enterocolitis, late-onset sepsis, death, gastrointestinal bleeding or perforation, diarrhoea, regurgitation, vomiting and abdominal distension.
Reported: No differences between groups on the primary outcomes in regression models. Diarrhoea, gastrointestinal perforation, necrotising enterocolitis and late-onset sepsis were absent in the LioNeo group, with one late-onset sepsis and one necrotising enterocolitis case in the comparison group. Authors concluded lyophilisation of donor human milk was safe and tolerable in haemodynamically stable very-low-birth-weight infants.
Limitations: Phase I safety and tolerability trial with only 40 infants, and only 21 days of follow-up; it is not powered to detect differences in rare outcomes such as necrotising enterocolitis or sepsis, and the authors frame it as safety and tolerability rather than efficacy. Milk was banked donor milk pooled and lyophilised under human milk bank and laboratory conditions, not a consumer home freeze dryer. Hospital NICU setting with medical supervision. Single centre, Brazil. This is the most substantial clinical trial identified and its sample size is 40.

Blackshaw K, Wu J, Valtchev P, Lau E, Banati RB, Dehghani F, Schindeler A (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia)
Foods

Year: 2021
Sample: not stated
Measured: Bacterial growth inhibition assays on donor human milk that was raw, Holder pasteurised, freeze-dried, or freeze-dried then gamma-irradiated at 2 to 50 kGy, using inoculants of Staphylococcus aureus, Salmonella typhimurium and Escherichia coli at 10^6 cfu/mL.
Reported: Freeze-drying followed by 2 kGy gamma irradiation was as efficient as Holder pasteurisation at reducing S. aureus and S. typhimurium inoculants. Human milk naturally inhibited growth of all three inoculants. Freeze-drying alone did not significantly reduce that natural growth inhibition, whereas Holder pasteurisation significantly reduced the milk's natural antimicrobial effect against S. aureus after 6 h (-19.8 percent, p=0.01).
Limitations: Sample number not stated in the abstract. Laboratory freeze-drying, not a consumer home freeze dryer. The bacterial kill step in this work is the gamma irradiation, not the freeze-drying: the paper does not establish that freeze-drying alone makes milk microbiologically safe. In vitro inoculation assay only, no infant outcomes. Authors declared no conflict of interest.

Jarzynka S, Strom K, Barbarska O, Pawlikowska E, Minkiewicz-Zochniak A, Rosiak E, Oledzka G, Wesolowska A (Medical University of Warsaw and Regional Human Milk Bank, Holy Family Hospital, Poland)
International Journal of Environmental Research and Public Health

Year: 2021
Sample: not stated
Measured: Concentration of bioactive components (insulin, adiponectin, leptin, pancreatic lipase activity, hepatocyte growth factor) and microbiological safety in raw, Holder pasteurised, high-pressure processed, and lyophilised donor human milk.
Reported: The combination of high-pressure processing plus freeze-drying best preserved nutritional and bioactive value while meeting microbiological safety criteria. The authors state explicitly that microbiological safety assessment excluded the possibility of using freeze-drying alone to preserve human milk samples, and that freeze-drying is suitable as a long-term storage method for milk already preserved by another process.
Limitations: Sample number not stated in the abstract. Laboratory and milk-bank equipment including a high-pressure processing rig, not a consumer home freeze dryer. The favourable result is for the combined high-pressure plus freeze-drying process, not freeze-drying alone. A correction to this article was published in 2024 (Int J Environ Res Public Health 2024;21(7):822). Authors declared no conflict of interest.

Hahn WH, Bae SP, Song S, Park S, Lee J, Seo JB, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea)
Journal of Maternal-Fetal and Neonatal Medicine

Year: 2020
Sample: 9 milk samples from 3 mothers (collected at 15 and 60 days of lactation)
Measured: Shotgun proteomic analysis by mass spectrometry of human milk before and after freeze-drying, with functional bioinformatic grouping of detected proteins.
Reported: 245 proteins were detected. Protein expression was not significantly affected by lactation period or by freeze-drying (p>.050), and functional analysis showed no significant difference. The authors themselves state that the number of samples was quite small to provide strong evidence, and that evaluation of safe storage length with respect to infectious agents and composition change after freeze-drying is warranted.
Limitations: Very small sample: 9 samples from only 3 mothers, and the authors explicitly flag this as too small for strong evidence. Laboratory lyophilisation, not a consumer home freeze dryer. Proteomic detection measures whether proteins are present, not whether bioactive proteins retain function. No microbiological safety endpoint and no storage-duration testing. Funding source not stated in the abstract.

Martysiak-Zurowska D, Rozek P, Puta M (Gdansk University of Technology, Poland)
Drying Technology

Year: 2020
Sample: not stated
Measured: Lysozyme activity, lactoferrin content, superoxide dismutase (SOD) activity, total antioxidant capacity (TAC) and fatty acid profile in pooled human milk that was freeze-dried and then stored for 6 weeks at 5C and at 25C. Water removal was also quantified.
Reported: Freeze-drying decreased water content by 86.5 percent and the lyophilisate was readily soluble. Freeze-drying did not affect SOD activity, fatty acid profile or lactoferrin content, decreased total antioxidant capacity by 22.1 percent, and produced a minor apparent increase in lysozyme activity of about 9.8 percent. Over 6 weeks of storage, TAC, lactoferrin, fatty acids and lysozyme were stable, but SOD activity fell by about 27 percent relative to the level immediately after lyophilisation.
Limitations: Milk was pooled, so individual variation is lost and no per-donor sample size is reported. Laboratory lyophilisation, not a consumer home freeze dryer. Storage window only 6 weeks, which is far shorter than the multi-year shelf life claimed by commercial services. Water content was reduced by 86.5 percent, which is a relative reduction and not the same as a stated residual moisture figure. No microbiological safety endpoint and no infant outcomes. Funding source not stated in the abstract.

Hahn WH, Kim J, Song S, Park S, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea)
Journal of Maternal-Fetal and Neonatal Medicine

Year: 2019
Sample: 9 milk samples from 3 mothers
Measured: Human milk oligosaccharide (HMO) profiles by MALDI TOF/TOF mass spectrometry, before and after Holder pasteurisation and freeze-drying.
Reported: HMO patterns differed significantly between mothers but were not affected by lactation period within the first 3 weeks. Correlation analysis found neither pasteurisation nor freeze-drying altered HMO patterns (r2 0.989 to 0.999, p<.001). Authors state that storage length without HMO composition change after freeze-drying still needs evaluation.
Limitations: Very small sample: 9 samples from only 3 mothers. Laboratory lyophilisation, not a consumer home freeze dryer. Single endpoint (HMO profile) measured immediately after processing, with no storage-duration testing, no microbiological endpoint and no infant outcomes. Milk was not pooled across a donor population, so between-mother variation dominates. Funding source not stated in the abstract.

Oliveira MM, Aragon DC, Bomfim VS, et al; Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil)
PLoS One

Year: 2019
Sample: not stated
Measured: Osmolality (freezing point osmometry) and macronutrient (MIRIS human milk analyser) and micronutrient (flame atomic absorption spectrophotometry and automated colorimetry) concentrations in baseline donor human milk and in human milk concentrates made with human milk lyophilisate, measured immediately and after 3 and 6 months of frozen storage.
Reported: Adding lyophilisate significantly increased energy, carbohydrate and total lipid concentration relative to baseline milk. Over storage, calcium and phosphorus rose and energy, total lipids and copper fell at 3 months; at 6 months calcium, magnesium, potassium, zinc and phosphorus rose while energy, total lipids and copper fell. The authors concluded the immediate concentrate is usable but that the partial stability of the concentrates over storage means they do not recommend storage.
Limitations: Preclinical laboratory study, not an infant feeding study; number of donors or samples not stated in the abstract. Milk-bank and laboratory lyophilisation, not a consumer home freeze dryer. The explicit negative finding is instability over 3 and 6 months of storage, with the authors advising against storing the concentrate. No immunological or microbiological endpoints. Authors declared no competing interests.

Manin LP, Rydlewski AA, Galuch MB, Pizzo JS, Zappielo CD, Senes CER, Santos OO, Visentainer JV (Universidade Estadual de Maringa, Brazil)
Journal of the Brazilian Chemical Society

Year: 2019
Sample: not stated
Measured: Acidity (Dornic degrees), lipid content, fatty acid composition (GC-FID) and major triacylglycerol profile (ESI-MS) of lyophilised, vacuum-packed colostrum, transitional and mature human milk at 1, 30, 60, 90, 120, 150 and 180 days of storage at -18C.
Reported: No significant differences in acidity, lipid content or fatty acid composition were observed across the 180-day period, and the relative percentage of major triacylglycerols was not altered. Authors concluded lyophilisation is a good alternative for human milk banks.
Limitations: Sample number not stated in the abstract. Milk was pasteurised before lyophilisation, so this is not raw milk. Laboratory lyophilisation with vacuum packing, not a consumer home freeze dryer. Critically, the lyophilised product was stored at -18C, that is, still frozen, so this study does not test ambient or pantry-temperature shelf stability, which is the claim made for consumer freeze-dried milk. Lipid endpoints only, no immunological or microbiological outcomes. Funding source not stated in the abstract.

Bomfim VS, Jordao AA Jr, Alves LG, Martinez FE, Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil)
PLoS One

Year: 2018
Sample: 50 donors
Measured: Total lipid content (MIRIS human milk analyser) and fatty acid profile (gas chromatography, CG-FID) in baseline donor human milk and in concentrates made with human milk lyophilisate, immediately and after 3 and 6 months of storage.
Reported: Lipid concentration was higher in the immediate concentrate than baseline milk. Palmitic acid changed significantly across conditions (p<0.01). Arachidonic acid fell from 0.35 percent of total fatty acids at baseline to 0.16 percent in the immediate concentrate and 0.13 to 0.15 percent on storage (p<0.01), and docosahexaenoic acid fell from 0.10 percent to 0.06 percent and 0.05 to 0.06 percent (p<0.01). Oleic, linoleic and alpha-linolenic acids did not change significantly. There were no significant changes in the lipid profile during storage and no evidence of peroxidation. Authors concluded further clinical studies are required to evaluate safety and efficacy.
Limitations: Preclinical laboratory study with no infant outcomes. Milk-bank and laboratory lyophilisation, not a consumer home freeze dryer; donor milk from a hospital human milk bank. The significant falls in arachidonic acid and docosahexaenoic acid are measured losses of long-chain polyunsaturated fatty acids relative to baseline milk. Authors declared no competing interests.

Kanaprach P, Pongsakul N, Apiwattanakul N, Muanprasat C, Supapannachart S, Nuntnarumit P, Chutipongtanate S (Mahidol University, Ramathibodi Hospital, Thailand)
Breastfeeding Medicine

Year: 2018
Sample: 10 pools produced from 40 independent donor milk specimens
Measured: Fetal intestinal cell growth assay and antimicrobial activity against Escherichia coli in donor milk after bacterial elimination (Holder pasteurisation or cold-sterilisation microfiltration) and after storage by freezing at -20C or by lyophilisation, at 0, 3 and 6 months.
Reported: Raw donor milk showed 193.1 +/- 12.3 percent fetal intestinal cell growth and 42.4 +/- 11.8 percent antimicrobial activity against E. coli. Over 6 months of storage, freezing preserved growth-promoting activity substantially better than lyophilisation (163.0 +/- 9.4 percent versus 72.8 +/- 6.2 percent, p<0.005). Antimicrobial activity was lost at 6 months regardless of storage method. Authors concluded donor milk should be used within 3 months after preparative processes.
Limitations: Milk was pooled: 10 pools from 40 specimens, so individual variation is not captured. Laboratory lyophilisation, not a consumer home freeze dryer. All storage arms were pasteurised or microfiltered first, so the lyophilisation arm is not raw milk. In vitro cell and antimicrobial assays, not infant outcomes. This is a directly negative finding for lyophilised storage at 6 months and is the clearest counterweight to the studies reporting preservation.

Castro Albarran J, Navarro Hernandez RE, Solis Pacheco JR, Salazar Quinones IC, Macias Lopez GG, Barrera de Leon JC, Aguilar Uscanga BR (Universidad de Guadalajara, Mexico)
Nutricion Hospitalaria

Year: 2017
Sample: not stated
Measured: Total protein (Lowry method) and concentrations of immunoglobulins A, G and M and complement C3 (nephelometry) in mature human milk pasteurised by three regimes (62.5C/30 min, 72C/15 min, 85C/5 min) and then freeze-dried in 30 mL volumes over 36 hours.
Reported: Pasteurisation at 62.5C gave the highest protein and immunoglobulin retention overall, but pasteurisation at 72C before freeze-drying showed better immunoglobulin retention. Authors concluded freeze-drying of pasteurised mature milk is a suitable conservation method for hospital milk banks.
Limitations: Descriptive study; sample number not stated in the abstract. Every arm was pasteurised before freeze-drying, so the study does not isolate the effect of freeze-drying alone and does not describe unpasteurised milk. Laboratory lyophiliser, not a consumer home freeze dryer. No control comparison against fresh unprocessed milk reported in the abstract, and no microbiological or clinical endpoints. Funding source not stated in the abstract.

Cortez MV, Soria EA (Universidad Nacional de Cordoba / CONICET, Argentina)
Breastfeeding Medicine

Year: 2016
Sample: 116
Measured: Protein, glucose, triglycerides, polyphenols and oxidative markers (nitrites, superoxide anion, hydroperoxides, lipoperoxides, gamma-glutamyl transpeptidase) in milk from 116 healthy women, compared across three treatments: frozen and held 6 months at -80C (control); freeze-dried 24 h at <=-70C and <=1.33 Pa then held 6 months at 4C; and freeze-dried then held 6 months at -80C.
Reported: Glucose decreased after freezing alone (p<0.05). All measured variables were conserved by freeze-drying, and the freeze-drying plus freezing combination did not improve on freeze-drying alone. Authors concluded freeze-drying achieved suitable conservation of nutritional properties, polyphenol-related functionality and oxidative integrity over the 6-month window tested.
Limitations: Laboratory lyophiliser operating at <=-70C and <=1.33 Pa (about 0.013 mbar); this is not the same process as a consumer home freeze dryer and the results cannot be assumed to transfer. Single centre, Argentina. Outcome set is nutrient and oxidative chemistry only: no immunoglobulin, lactoferrin, lysozyme or microbiological safety endpoints. Storage window limited to 6 months. Residual moisture of the dried product not reported in the abstract. Funding source not stated in the abstract.

Castro-Albarran J, Aguilar-Uscanga BR, Calon F, St-Amour I, Solis-Pacheco J, Saucier L, Ratti C (Universidad de Guadalajara, Mexico; Universite Laval, Canada)
Drying Technology

Year: 2016
Sample: not stated
Measured: Retention of immunoglobulins IgA, IgG and IgM in human milk powder produced by spray drying and by freeze drying at different heating plate temperatures, with residual humidity of the powders recorded.
Reported: Spray drying produced powders at about 2 percent humidity with retention above 88 percent for IgG and about 70 percent for IgM, but only about 38 percent of IgA remained. For freeze drying, the highest heating plate temperature tested (40C) reduced IgA to about 55 percent in powder with 1.75 percent residual humidity, while lower plate temperatures gave higher retention, about 75 percent for IgA and about 80 percent for IgG and IgM, with correspondingly higher residual moisture. Authors concluded IgA is the immunoglobulin most sensitive to drying, and that freeze drying at a 30C plate temperature was the best compromise.
Limitations: Sample number not stated. Laboratory spray dryer and laboratory freeze dryer, not a consumer home freeze dryer, and the key variable driving the result (heating plate temperature) is a parameter a consumer machine does not expose or control in the same way. Note the direct trade-off the study documents: lower plate temperature preserved more immunoglobulin but left more residual moisture in the powder, and residual moisture is itself a storage-stability and microbiological risk factor. Even at best, IgA retention was about 75 percent, that is, a measurable loss. Published in a drying engineering journal; funding source not stated in the sources accessed.

Salcedo J, Gormaz M, Lopez-Mendoza MC, Nogarotto E, Silvestre D (University Cardenal Herrera-CEU and Hospital La Fe Human Milk Bank, Valencia, Spain)
Journal of Pediatric Gastroenterology and Nutrition

Year: 2015
Sample: 125 milk samples from 65 healthy donors
Measured: Microbiological content, bactericidal activity, sialic acid and ganglioside content, and protein, fat and lactose concentrations, compared across lyophilisation and freezing at -20C and at -80C.
Reported: Lyophilisation and storage at -80C significantly reduced counts of mesophilic aerobic microorganisms and Staphylococcus epidermidis compared with storage at -20C. Bactericidal activity was not significantly changed by lyophilisation compared with freezing at either temperature. Bactericidal activity was not correlated with fat, protein or lactose but was correlated with ganglioside content, and was significantly greater in mature milk and in milk from term deliveries.
Limitations: Laboratory or milk-bank lyophiliser, not a consumer home freeze dryer. Donor milk from a hospital milk bank collected under milk-bank hygiene protocols, so the microbiological starting point is not comparable to home expression and handling. Reduction in bacterial counts is relative to frozen storage, not evidence of a validated kill step. No infant clinical outcomes. Funding source not stated in the abstract.

Lozano B, Castellote AI, Montes R, Lopez-Sabater MC (University of Barcelona, Spain)
International Journal of Food Sciences and Nutrition

Year: 2014
Sample: 72
Measured: Vitamin C (ascorbic acid and total), tocopherols, antioxidant capacity and fatty acid composition in 72 samples of freeze-dried human milk stored for up to 3 months at either 4C or 40C.
Reported: Ascorbic acid and total vitamin C concentrations decreased significantly at both storage temperatures. Antioxidant capacity decreased only at 40C. Fatty acid composition and gamma-tocopherol and delta-tocopherol content remained unaltered. Authors reported stability after storage of freeze-dried milk was higher than previously reported for frozen or fresh milk.
Limitations: Laboratory lyophilisation, not a consumer home freeze dryer. Maximum storage window tested was 3 months, so longer-term stability is not addressed. Vitamin C loss is a measured negative finding. No immunological or microbiological endpoints. Residual moisture not reported in the abstract. Whether samples were pooled is not stated in the abstract. Funding source not stated in the abstract.

"Sample" is the figure the paper itself states. Where a paper states none, this table says so rather than estimating one from the method section.

Freeze drying is not a kill step

One point recurs across the literature and is worth stating on its own, because it is frequently misunderstood. Freeze drying removes water. It is not a thermal process and it is not a pasteurisation step. One study excluded freeze drying on its own on microbiological grounds, and in the Australian research the reduction in pathogens came from gamma irradiation applied after drying rather than from the drying. Milk that carried a contamination risk beforehand still carries it afterwards.

What Australian bodies have said

We checked 8 Australian organisations. 6 of them have published nothing on this subject. That is the finding, not a failure to find one: several of these are exactly the bodies a person would expect to have looked at it.

What Australian bodies have saidSourced, dated, checkable
Body	Published position
Food Standards Australia New Zealand (FSANZ)	No published position specifically on freeze drying breast milk as at 12 September 2026. FSANZ has published imported food risk advice covering human milk and human milk products generally, which does not mention freeze-dried, dried, powdered or lyophilised human milk.
Australian Breastfeeding Association (ABA)	No position published on freeze drying breast milk as at 12 September 2026. The ABA's expressed breastmilk storage guidance covers refrigeration and freezing only and does not mention freeze-drying, dehydrating, powdering or lyophilising.
Therapeutic Goods Administration (TGA)	No position published on freeze drying breast milk as at 12 September 2026. The only TGA reference to human breast milk located is in export guidance, where breast milk is explicitly outside the TGA export permit system and the TGA refers people to state and territory health departments.
Australian Red Cross Lifeblood (Lifeblood Milk)	Does not freeze dry. Lifeblood's published process for pasteurised donor human milk is Holder pasteurisation followed by frozen storage, with a 3 month expiry. Freeze-drying and lyophilisation are not mentioned anywhere in its milk program material, and no Lifeblood position on freeze drying was located as at 12 September 2026.
Australian Competition and Consumer Commission (ACCC)	No position, guidance or enforcement action published specifically on freeze-dried breast milk or breast milk freeze-drying services as at 12 September 2026. Only the general Australian Consumer Law framework applies.
Australian state and territory health departments	No position located from any Australian state or territory health department on freeze drying breast milk as at 12 September 2026. The relevant state guidelines cover refrigeration and freezing only and are silent on freeze-drying.
Royal Australian College of General Practitioners (RACGP)	No position published on freeze drying breast milk as at 12 September 2026.
Mothers Milk Bank Charity (Brisbane, Australia)	Sells freeze-dried pasteurised donated human milk directly to families. This is a milk bank that has adopted freeze-drying, not a body that has issued a position on the safety of the practice generally, and its process pasteurises before freeze-drying.

What Australian bodies have saidSourced, dated, checkable

Food Standards Australia New Zealand (FSANZ)

Published position: No published position specifically on freeze drying breast milk as at 12 September 2026. FSANZ has published imported food risk advice covering human milk and human milk products generally, which does not mention freeze-dried, dried, powdered or lyophilised human milk.

Australian Breastfeeding Association (ABA)

Published position: No position published on freeze drying breast milk as at 12 September 2026. The ABA's expressed breastmilk storage guidance covers refrigeration and freezing only and does not mention freeze-drying, dehydrating, powdering or lyophilising.

Therapeutic Goods Administration (TGA)

Published position: No position published on freeze drying breast milk as at 12 September 2026. The only TGA reference to human breast milk located is in export guidance, where breast milk is explicitly outside the TGA export permit system and the TGA refers people to state and territory health departments.

Australian Red Cross Lifeblood (Lifeblood Milk)

Published position: Does not freeze dry. Lifeblood's published process for pasteurised donor human milk is Holder pasteurisation followed by frozen storage, with a 3 month expiry. Freeze-drying and lyophilisation are not mentioned anywhere in its milk program material, and no Lifeblood position on freeze drying was located as at 12 September 2026.

Australian Competition and Consumer Commission (ACCC)

Published position: No position, guidance or enforcement action published specifically on freeze-dried breast milk or breast milk freeze-drying services as at 12 September 2026. Only the general Australian Consumer Law framework applies.

Australian state and territory health departments

Published position: No position located from any Australian state or territory health department on freeze drying breast milk as at 12 September 2026. The relevant state guidelines cover refrigeration and freezing only and are silent on freeze-drying.

Royal Australian College of General Practitioners (RACGP)

Published position: No position published on freeze drying breast milk as at 12 September 2026.

Mothers Milk Bank Charity (Brisbane, Australia)

Published position: Sells freeze-dried pasteurised donated human milk directly to families. This is a milk bank that has adopted freeze-drying, not a body that has issued a position on the safety of the practice generally, and its process pasteurises before freeze-drying.

The referral that leads nowhere. The TGA's published material on human milk refers people to state and territory health departments. Those departments' storage guidance covers refrigeration and freezing and does not mention drying, powdering or lyophilisation at all. So the one pointer a person following official channels would follow ends at a document that does not address the question.

The Australian organisations that do say something are not regulators taking a position on the practice: they are Australian Red Cross Lifeblood and Mothers Milk Bank Charity, describing what they themselves do.

Overseas positions

Listed separately and clearly, because none of these applies in Australia and it would be misleading to present them as though they did.

Overseas positionsSourced, dated, checkable
Body	Position
US Food and Drug Administration (FDA)	The FDA has no rule or approval process specific to freeze-dried breast milk. Its published position concerns donor human milk generally: it recommends against feeding a baby breast milk acquired directly from individuals or over the internet.
Human Milk Banking Association of North America (HMBANA)	No published HMBANA position statement specifically on freeze-dried human milk was located as at 12 September 2026. HMBANA's accredited-milk-bank standard remains Holder pasteurised donor human milk, and freeze-dried products are outside that standard.
Alberta Health Services, Nutrition Services (CANADA, NOT AUSTRALIA)	Does not recommend the use of freeze-dried human milk, in reconstituted form or as a fortifier, in any setting.
US Centers for Disease Control and Prevention (CDC)	No position on freeze drying breast milk located on cdc.gov as at 12 September 2026. CDC breast milk storage guidance covers refrigeration and freezing only.

Overseas positionsSourced, dated, checkable

US Food and Drug Administration (FDA)

Position: The FDA has no rule or approval process specific to freeze-dried breast milk. Its published position concerns donor human milk generally: it recommends against feeding a baby breast milk acquired directly from individuals or over the internet.

Human Milk Banking Association of North America (HMBANA)

Position: No published HMBANA position statement specifically on freeze-dried human milk was located as at 12 September 2026. HMBANA's accredited-milk-bank standard remains Holder pasteurised donor human milk, and freeze-dried products are outside that standard.

Alberta Health Services, Nutrition Services (CANADA, NOT AUSTRALIA)

Position: Does not recommend the use of freeze-dried human milk, in reconstituted form or as a fortifier, in any setting.

US Centers for Disease Control and Prevention (CDC)

Position: No position on freeze drying breast milk located on cdc.gov as at 12 September 2026. CDC breast milk storage guidance covers refrigeration and freezing only.

One claim to disregard. A line stating that the United States Centers for Disease Control has said freeze dried breast milk "has not been adequately studied" circulates widely. We could not locate it on any CDC page. We are not saying the CDC holds the opposite view; we are saying the quotation could not be attributed, and an unattributable quotation from a health authority is worth less than nothing.

Services operating in Australia

Recorded factually, with their own claims attributed to them. We have not assessed these businesses and we earn nothing from any of them.

Services operating in AustraliaSourced, dated, checkable
Service	Location	What they do	What they claim
Nourishy	Northgate, Brisbane, QLD; ships Australia-wide, plus drop-off locations	Commercial freeze-drying of a mother's own expressed breast milk. Customers send frozen milk in a shipping kit or drop it off; the company freeze-dries it and returns it as powder. The company also separately distributes freeze-dried pasteurised donor human milk for hospital use.	The company states the service will 'Turn your frozen breast milk into convenient, shelf-stable powder' that is '100% your milk, with only the water removed', with 'Up to 3 years' shelf life' and 'up to three years from the freeze-drying date when stored in a cool, dry place'. It states it operates 'out of a licensed, fully-certified Brisbane facility'. It claims 'Every order undergoes water-activity testing and is sealed in validated high-barrier packaging'; that milk 'never comes into direct contact with freeze-drying equipment or machinery'; and that milk is processed individually with 'no pooling or mixing'. On nutrition it claims 'Freeze-drying removes water while helping preserve the nutritional and bioactive properties' and that its testing 'found no significant reduction in key macronutrients, including protein, fat, carbohydrates and calories'. Pricing is stated as shipping kits from 240 AUD including shipping, or drop-off from 6.50 AUD per 100 g of frozen milk. Its research page curates 18 peer-reviewed studies dated 1953 to 2021 rather than presenting company-generated efficacy data. There is no statement on the pages reviewed that a mother's own milk is pasteurised as part of this service. All of the above are the company's own claims, recorded here as claims. Note of fact, not assessment: both Nourishy and The Milk Fairy describe themselves as Australia's first breast milk freeze-drying service. Those two claims cannot both be correct; neither was verified for this dataset.
The Milk Fairy	Geelong, Victoria	Commercial freeze-drying of a mother's own expressed breast milk, by shipping kit or local drop-off.	The company describes itself as '100% Australian owned Geelong, Victoria' and 'Australia's first breast milk freeze-drying service'. It claims the product is 'Shelf stable to 3 years' when sealed and lasts '3 days once a pouch is opened'. On process it states 'Freeze-drying removes water without heat, the things that make your milk valuable stay intact' and describes temperature control as 'roughly the temperature your milk left your body at'. On testing it states 'Lab tested. Every batch is measured for water activity before it leaves us' and 'Moisture tested before it comes home'. It states milk 'is processed individually and completely separately in Pure Protect pouches' and is 'Never pooled with another mum's milk'. Pricing is stated as 'From $290.00 AUD' for the shipping service and 'from $90 per litre ex GST' for local drop-off. Pasteurisation is not mentioned anywhere on the site reviewed, and no safety disclaimer was found. All of the above are the company's own claims, recorded here as claims. Note of fact, not assessment: both The Milk Fairy and Nourishy describe themselves as Australia's first breast milk freeze-drying service. Those two claims cannot both be correct; neither was verified for this dataset.
Mothers Milk Bank Charity	Brisbane, QLD	Non-profit milk bank that screens donors, pasteurises and then freeze-dries donated human milk, and sells the freeze-dried pasteurised donated human milk (PDHM) in sachets direct to families, alongside a frozen PDHM product.	The charity states the milk is 'dosed into 100ml bottles, pasteurised and then freeze-dried', producing a 'shelf-stable powder that lasts for three years' that 'does not require refrigeration'. It claims 'The milk retains all its nutrients'. On screening it states donors pass 'an initial assessment' and blood tests, and that 'Pre and post-pasteurisation samples undergo external microbial testing before being made available for consumption'. Reconstitution instruction given is to mix each sachet 'with 90ml of warm, cooled-boiled or purified water'. Listed price range 180 to 1,800 AUD for 10 to 100 sachets, which the charity describes as covering collection, cold freight, pasteurisation, freeze-drying, packaging, testing and distribution rather than payment for the milk itself. This is donor milk from screened third-party donors, not a mother's own milk. All of the above are the charity's own claims, recorded here as claims.

Services operating in AustraliaSourced, dated, checkable

Nourishy

Location: Northgate, Brisbane, QLD; ships Australia-wide, plus drop-off locations
What they do: Commercial freeze-drying of a mother's own expressed breast milk. Customers send frozen milk in a shipping kit or drop it off; the company freeze-dries it and returns it as powder. The company also separately distributes freeze-dried pasteurised donor human milk for hospital use.
What they claim: The company states the service will 'Turn your frozen breast milk into convenient, shelf-stable powder' that is '100% your milk, with only the water removed', with 'Up to 3 years' shelf life' and 'up to three years from the freeze-drying date when stored in a cool, dry place'. It states it operates 'out of a licensed, fully-certified Brisbane facility'. It claims 'Every order undergoes water-activity testing and is sealed in validated high-barrier packaging'; that milk 'never comes into direct contact with freeze-drying equipment or machinery'; and that milk is processed individually with 'no pooling or mixing'. On nutrition it claims 'Freeze-drying removes water while helping preserve the nutritional and bioactive properties' and that its testing 'found no significant reduction in key macronutrients, including protein, fat, carbohydrates and calories'. Pricing is stated as shipping kits from 240 AUD including shipping, or drop-off from 6.50 AUD per 100 g of frozen milk. Its research page curates 18 peer-reviewed studies dated 1953 to 2021 rather than presenting company-generated efficacy data. There is no statement on the pages reviewed that a mother's own milk is pasteurised as part of this service. All of the above are the company's own claims, recorded here as claims. Note of fact, not assessment: both Nourishy and The Milk Fairy describe themselves as Australia's first breast milk freeze-drying service. Those two claims cannot both be correct; neither was verified for this dataset.

The Milk Fairy

Location: Geelong, Victoria
What they do: Commercial freeze-drying of a mother's own expressed breast milk, by shipping kit or local drop-off.
What they claim: The company describes itself as '100% Australian owned Geelong, Victoria' and 'Australia's first breast milk freeze-drying service'. It claims the product is 'Shelf stable to 3 years' when sealed and lasts '3 days once a pouch is opened'. On process it states 'Freeze-drying removes water without heat, the things that make your milk valuable stay intact' and describes temperature control as 'roughly the temperature your milk left your body at'. On testing it states 'Lab tested. Every batch is measured for water activity before it leaves us' and 'Moisture tested before it comes home'. It states milk 'is processed individually and completely separately in Pure Protect pouches' and is 'Never pooled with another mum's milk'. Pricing is stated as 'From $290.00 AUD' for the shipping service and 'from $90 per litre ex GST' for local drop-off. Pasteurisation is not mentioned anywhere on the site reviewed, and no safety disclaimer was found. All of the above are the company's own claims, recorded here as claims. Note of fact, not assessment: both The Milk Fairy and Nourishy describe themselves as Australia's first breast milk freeze-drying service. Those two claims cannot both be correct; neither was verified for this dataset.

Mothers Milk Bank Charity

Location: Brisbane, QLD
What they do: Non-profit milk bank that screens donors, pasteurises and then freeze-dries donated human milk, and sells the freeze-dried pasteurised donated human milk (PDHM) in sachets direct to families, alongside a frozen PDHM product.
What they claim: The charity states the milk is 'dosed into 100ml bottles, pasteurised and then freeze-dried', producing a 'shelf-stable powder that lasts for three years' that 'does not require refrigeration'. It claims 'The milk retains all its nutrients'. On screening it states donors pass 'an initial assessment' and blood tests, and that 'Pre and post-pasteurisation samples undergo external microbial testing before being made available for consumption'. Reconstitution instruction given is to mix each sachet 'with 90ml of warm, cooled-boiled or purified water'. Listed price range 180 to 1,800 AUD for 10 to 100 sachets, which the charity describes as covering collection, cold freight, pasteurisation, freeze-drying, packaging, testing and distribution rather than payment for the milk itself. This is donor milk from screened third-party donors, not a mother's own milk. All of the above are the charity's own claims, recorded here as claims.

Two of these describe themselves as Australia's first such service. Both statements cannot be true, and we have not established which is. It is a small thing, and it is the kind of small thing worth noticing when you are assessing a claim about your own child's milk.

Where to take this

If you are considering it, the useful next step is not more reading on sites like this one. It is a conversation with your doctor, midwife or a lactation consultant, and the questions worth taking to them are the ones the literature has not settled: what a home machine achieves compared with the laboratory equipment every study used, what residual moisture is acceptable, and what the absence of any Australian guidance means for your situation.

If you came here from the machines rather than from the milk, the rest of this site is about what these appliances do to food, which is a considerably simpler subject and one we are qualified to write about.

Common questions

Is freeze drying breast milk safe?

We are not going to answer that, and we would be the wrong source if we did. This is an appliance comparison site, the question is a clinical one, and it belongs with your doctor, your midwife or a lactation consultant. What this page does instead is set out what the published studies measured, what they found, how small they were, and what Australian authorities have and have not said, so that you can take an informed question to someone qualified to answer it.

Has anyone studied home freeze dryers specifically?

No. That is the clearest gap in the literature. Every study we located used laboratory, pilot-scale, milk-bank or industrial equipment. None tested milk processed on a consumer machine of the kind this site otherwise writes about, so the published results cannot simply be assumed to describe what a domestic appliance produces.

Does freeze drying kill bacteria in milk?

The published work indicates it does not. Freeze drying removes water; it is not a thermal kill step. One study excluded freeze drying on its own on microbiological grounds, and in the Australian research the pathogen reduction came from gamma irradiation applied after drying rather than from the drying itself. Milk that was unsafe before the process is not made safe by it.

What do Australian regulators say?

Almost nothing, and that is itself worth knowing. Of the 8 Australian bodies we checked, 6 have published no position on freeze drying human milk at all. The TGA refers questions on human milk to state and territory health departments, and those departments have published nothing on drying or powdering either, so the referral leads nowhere. An absence of guidance is not the same thing as approval.

The gap that matters most

What the research covers

The studies

Ward A, Reyes SM, Luck B, Serke L, Figard L, Kimball A (UChicago Medicine AdventHealth; Milkify Inc, Houston, Texas; Rev Bioscience; Rady Children's Hospital San Diego) American Journal of Perinatology Reports

Alvarado Chavarria P, Shah FS, Hafeez A, Zafar S, Khan K (Vyarna OU, Estonia; National University of Sciences and Technology, Pakistan) Microbial Pathogenesis

Not fully recorded; published in Food Biophysics Food Biophysics

Rochow N, Weiss GA, Knab K, et al; Fusch C (Paracelsus Medical University Nuremberg, Germany; Rostock University Medical Center; McMaster University) Nutrients

Reyes SM, Allen DL, Williams JE, McGuire MA, McGuire MK, Rasmussen KM, Hay AG (Cornell University; Rev Bioscience LLC; University of Idaho) Journal of Translational Medicine

Sproat TDR, Ghosh A, Alshaikh BN (University of Calgary; Royal Victoria Infirmary, Newcastle) Journal of Perinatology

Davila-Caraballo GJ, Serrato-Marquez E, Grimaldo-Rivas MD, Chuck-Hernandez CE, Vega-Cantu YI, Ortega-Alonzo SE, Coronado-Cerda E, Urrutia-Baca VH (Mexico) Journal of Food Composition and Analysis

Blackshaw K, Wu J, Proschogo N, Davies J, Oldfield D, Schindeler A, Banati RB, Dehghani F, Valtchev P (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia) Food Chemistry

Nogueira-Pileggi V, Achcar MC, Carmona F, et al; Camelo Junior JS (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) British Journal of Nutrition

Blackshaw K, Wu J, Valtchev P, Lau E, Banati RB, Dehghani F, Schindeler A (University of Sydney; ANSTO; Mothers Milk Bank Charity, Australia) Foods

Jarzynka S, Strom K, Barbarska O, Pawlikowska E, Minkiewicz-Zochniak A, Rosiak E, Oledzka G, Wesolowska A (Medical University of Warsaw and Regional Human Milk Bank, Holy Family Hospital, Poland) International Journal of Environmental Research and Public Health

Hahn WH, Bae SP, Song S, Park S, Lee J, Seo JB, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea) Journal of Maternal-Fetal and Neonatal Medicine

Martysiak-Zurowska D, Rozek P, Puta M (Gdansk University of Technology, Poland) Drying Technology

Hahn WH, Kim J, Song S, Park S, Kang NM (Soon Chun Hyang University and Konkuk University, Republic of Korea) Journal of Maternal-Fetal and Neonatal Medicine

Oliveira MM, Aragon DC, Bomfim VS, et al; Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) PLoS One

Manin LP, Rydlewski AA, Galuch MB, Pizzo JS, Zappielo CD, Senes CER, Santos OO, Visentainer JV (Universidade Estadual de Maringa, Brazil) Journal of the Brazilian Chemical Society

Bomfim VS, Jordao AA Jr, Alves LG, Martinez FE, Camelo JS Jr (Ribeirao Preto Medical School, University of Sao Paulo, Brazil) PLoS One

Kanaprach P, Pongsakul N, Apiwattanakul N, Muanprasat C, Supapannachart S, Nuntnarumit P, Chutipongtanate S (Mahidol University, Ramathibodi Hospital, Thailand) Breastfeeding Medicine

Castro Albarran J, Navarro Hernandez RE, Solis Pacheco JR, Salazar Quinones IC, Macias Lopez GG, Barrera de Leon JC, Aguilar Uscanga BR (Universidad de Guadalajara, Mexico) Nutricion Hospitalaria

Cortez MV, Soria EA (Universidad Nacional de Cordoba / CONICET, Argentina) Breastfeeding Medicine

Castro-Albarran J, Aguilar-Uscanga BR, Calon F, St-Amour I, Solis-Pacheco J, Saucier L, Ratti C (Universidad de Guadalajara, Mexico; Universite Laval, Canada) Drying Technology

Salcedo J, Gormaz M, Lopez-Mendoza MC, Nogarotto E, Silvestre D (University Cardenal Herrera-CEU and Hospital La Fe Human Milk Bank, Valencia, Spain) Journal of Pediatric Gastroenterology and Nutrition

Lozano B, Castellote AI, Montes R, Lopez-Sabater MC (University of Barcelona, Spain) International Journal of Food Sciences and Nutrition