The Donor Difference
Counting protocolProducts GMP
GMP products
High-tier starting materials for clinical and commercial manufacturing, made under FDA 21 CFR 1271 and a full quality management system. Over 20 years in the industry, 99% GMP collections deliverability.
CleanroomISO 7 · Grade A/BDeliverability99%Standard21 CFR 1271
Portfolio
GMP product line
GMPGMP Fresh Leukopak
Lymphocyte-rich, ≥90% viability, 2–8 °C.
Learn moreGMPGMP Cryopreserved Leukopak
Made-to-stock or custom, ISO 7 cleanroom.
Learn more
GMPGMP Mobilized Leukopak
Large-scale CD34+ HSPC collections.
Learn more
GMPGMP Bone Marrow
HSCs and MSCs for multi-lineage work.
Learn more
GMPGMP Cryopreserved PBMCs
Ready-to-use vials, off the shelf.
Learn moreSomething else?
Products outside the portfolio can be requested through your account representative.
Learn moreCompliance
Donor eligibility and testing
- Infectious disease
- Per 21 CFR 1271 plus CDC and AABB recommended tests
- Donor exam
- Physical exam and donor health questionnaire
- Consent
- IRB-approved for research and commercial use
- Manufacture
- 21 CFR 1271 Subparts A–C plus applicable Subpart D under §1271.150(c)
- QMS
- Batch records, equipment and product validation, stability studies
- Packaging
- Validated to ISTA standards, temperature logger included
| Agent | Marker |
|---|---|
| HIV-1 / HIV-2 | Antibodies + RNA |
| Hepatitis B | Antibodies + DNA |
| Hepatitis C | Antibodies + RNA |
| HTLV I / II | Antibodies |
| CMV | Antibodies |
| West Nile virus | RNA |
| T. cruzi (Chagas) | Antibodies |
| T. pallidum (syphilis) | Antibodies |
Donors are also characterized for HLA and KIR typing, CMV status, blood type, demographics and lifestyle.
Risk
Risk mitigation built in
- Infectious disease screening at multiple time points
- Backup donors and parallel donors
- Shipping advice ahead of severe weather