Collection of Postnatal Donation A Recovery Specialist, once given the donation information from the Director of Procurement, will collect the postnatal donation at the designated hospital. The Recovery Specialist will then return the donation to UCB to be processed.
Donor Eligibility Requirement Our proprietary process begins with meticulous screening of the donor mother and father as well as family members for several generations. In addition to routine industry screens for blood borne pathogens, we also screen for heritable and non-heritable conditions, environmental contaminants from medications, alcohol, drugs, tobacco and electronic vaping. Only healthy families who meet or exceed these criteria are considered. Postnatal tissues can be collected within 30 minutes of a Cesarean section. After processing, allografts are tested again to ensure they are free of contaminants or infection, and contain healthy, viable cells prior to cryopreservation.
Testing Procedures Include:
- Communicable disease testing performed by a CLIA certified lab.
- Before the release and distribution of any product, our lots are quarantined for 14 days and thoroughly tested for bacterial contamination.
- Plate testing is conducted in multiple phases of the production process to ensure there is zero contamination.
Diseases that are tested prior to donation eligibility:
- Hepatitis Bs Ag
- Hepatitis Bc Ab
- HTLV I/II Ab
- Hepatitis C Ab
- HIV 1&2 Plus O Ab
- CMV ab
- RPR (Non-treponemal syphilis)
- HIV-1/HCV/HBV NAT (Ultrio)
- WNV NAT
Processing this proprietary process meets the FDA’s requirements being minimally manipulated, include:
For structural tissue, processing that does not alter the original relevant characteristics of the tissue related to the tissue’s utility for reconstruction, repair or replacement; and
For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
Transfer means the placement of human reproductive cells or tissues into a human recipient.
Cryopreservation: We use a unique cryopreservation technique that includes using the donation’s own natural components integrated with a natural cryoprotectant to help ensure maximum functional cells post-thaw for homologous use.
Shipping: Our products are shipped overnight in cryopreserved authorized shipping containers. Products are shipped only to licensed medical professionals.