Standards · Donor Eligibility
Donor eligibility.
Where the product chain originates from human donor source material, donor eligibility records are held consistent with 21 CFR Part 1271 Subpart C. The framework below describes the screening and testing standards applied across the upstream supply chain.
Scope
Donor eligibility documentation applies to products derived from human donor source material — including umbilical cord blood (Altogex), umbilical cord tissue (CytoCord), extracellular vesicles derived from human donor cell sources (ExCyte), and applicable Nexa Biologix preparations (HPL-SER, LEUKO-SER variants, BM-SER, BMSC, ASCS, BMCD34, and others sourced from human donors).
Donor screening
Donor screening is conducted before donation. Screening evaluates the donor's relevant medical records for risk factors and clinical evidence of relevant communicable disease agents and disease conditions, as required by 21 CFR 1271.75 and 21 CFR 1271.85.
Screening covers, at minimum:
- HIV (human immunodeficiency virus, types 1 and 2)
- HBV (hepatitis B virus)
- HCV (hepatitis C virus)
- Treponema pallidum (syphilis)
- HTLV (human T-lymphotropic virus, types I and II), where applicable
- Cytomegalovirus, where applicable
- WNV (West Nile virus), where applicable
- Trypanosoma cruzi (Chagas disease), where applicable
- Vaccinia virus (smallpox vaccination history), where applicable
- Sepsis and transmissible spongiform encephalopathy, where applicable
Donor testing
Donor testing is performed using FDA-licensed, approved, or cleared screening tests on a specimen drawn at the time of donation (or within an acceptable window of donation, per 21 CFR 1271.80). Reactive results are followed up per the manufacturer's qualified protocol. Donors whose test results indicate ineligibility are excluded.
Donor eligibility determination
A determination of donor eligibility is documented for each donor based on the screening and testing results, consistent with 21 CFR 1271.50. Eligibility determinations are reviewed and signed off before donor source material is released for processing.
Documentation and traceability
Donor eligibility records are linked to lot release documentation through donor identifier. A customer ordering a specific lot can request, through their verified account, confirmation that the donor eligibility determination is on file. Donor personally identifiable information is not disclosed to customers.
Exceptions and labeling
Where a donor does not meet eligibility criteria but the source material is shipped for non-clinical research use under appropriate labeling and acknowledgment, the label and Certificate of Analysis identify the lot accordingly. ExoBioCorp does not ship ineligible-donor material under representations of eligibility.