SCREENING

•     Extensive donor medical & social profile
•     Incoming raw milk is quarantined until acceptance testing is complete
•     Milk - nutritional value assessment

SPECIFIC TESTING

•     Drugs of abuse
•     Donor DNA matching
•     Bioburden testing & speciation

PASTEURIZATION & PROCESSING

•     Externally validated viral and bacterial inactivation processes

FINAL PRODUCT QC TESTING

•    Finished goods are quarantined until results are received from the 3rd party labs for the following:
  
  
  •     PCR testing
  •     Bioburden testing & speciation
  •     Nutrition label analysis

Immunoglobulin A (IgA) and secretory IgA (s[IgA2]) were quantitated in human milk samples using sandwich ELISA procedures. Following pasteurization using the Prolacta® HTST process, IgA concentration declined 27 percent, on average, and secretory IgA levels declined 17 percent compared to the corresponding values in untreated human milk samples.

Lysozyme content was determined by a microtiter assay using a Micrococcus lysodeikticus suspension as substrate. The lysozyme activity in human milk after pasteurization was 22,000 IU/mL, 57 percent of the initial activity (39,000 IU/mL) in pretreated raw human milk.

Lactoferrin concentration was determined by an ELISA technique. The lactoferrin content of human milk after pasteurization was 0.033 g/100 mL, 14 percent of the initial concentration (0.24 g/100 mL) in pretreated raw human milk. This is consistent with the published literature on the effect of pasteurization on the components of human milk.[2]

Vitamin analyses were performed by validated HPLC procedures. Vitamin A, vitamin C, and α-, γ-, and δ-tocopherol levels remained unchanged following pasteurization. The vitamin B6 content of human milk slightly decreased to 7.8 µg/100 mL, about 89 percent of the initial concentration of 8.8 µg/100 mL. These results are summarized in Table 2.

Table 2. Effect of Prolacta Pasteurization Conditions on Human Milk Constituents

[1] Jensen RG (ed): Handbook of Milk Composition. San Diego, Academic Press, 1995.

[2] Wills ME, Han VEM, Harris DA, Baum JD. Short-term low-temperature pasteurization of human milk. Early Human Develop., 7;71-80, in R.A. Lawrence and R.M Lawrence, "Breastfeeding: A Guide for the Medical Profession", Fifth Edition, C. V. Mosby, 1998, p. 687.

1. Similar to the blood donor industry, prior to a mother donating she is screened through a medical questionnaire. Unlike with blood donation, however, the mother must have written approval from both her own doctor and her baby’s pediatrician prior to donating.
2. Once the medical questionnaire is submitted, the potential donor is entered into Prolacta’s proprietary database.
3. If the potential donor passes the medical screening questionnaire, and has physician and pediatrician approval, a phlebotomist is sent to the mother’s home for blood to be drawn and tested.
4. The blood test screens for several infectious agents including HTLV 1 & 2, hepatitis B, C, HIV 1 and 2, and syphilis.
5. The potential donor mother’s cheek is swabbed to provide a DNA donor ID.
6. If the mother passes screening and meets all of the requirements outlined above, she can donate her breast milk.
7. After the milk arrives at Prolacta, it is tested for the 5 most common drugs of abuse, bacterial contamination and foreign (non-human) proteins.
8. A DNA test is conducted to match the donor mother to the actual milk donated.
9. If all tests pass, then the breast milk can be processed.
10. Processing takes place in Prolacta’s pharmaceutical grade clean rooms with state of the art equipment -- there is nothing like it in the world. Prolacta has a proprietary process that is Legal Pasteurization as defined by the FDA (http://www.cfsan.fda.gov/~ear/pmo01-2.html), used to kill bacteria and viruses.
11. Additionally, Prolacta uses PCR technology for final release testing for the presence of viruses.
12. Prolacta then tests the final product for levels of bacteria ten times lower than the industry standard.
13. Each product has a complete nutritional facts label, determined from testing by an accredited third-party lab.
14. Prolacta products are made to exacting specifications as defined by experts in the field of neonatal nutrition for protein, fat, and calories.

To address the growing need for human milk formulations, Prolacta Bioscience developed the nation’s first large-scale, centralized facility to process breast milk in a pharmaceutical-grade setting. Using state-of-the-art formulation, pasteurization and filling processes that minimize the loss of beneficial components of breast milk and maximize the destruction of harmful microorganisms, Prolacta formulates to an exact standard to meet the needs of very low birth weight babies during the first 30 days of life.