Sequential isolation
The Donor Difference
Counting protocolQuality system
Protocols designed so AllCells® products and services consistently deliver high quality, viability and purity.
Regulatory framework
Overview
Our Quality Management System follows the ICH Q10 pharmaceutical quality system model and aligns with 21 CFR Part 1271 (HCT/Ps) and 21 CFR Part 630 (blood and blood components for transfusion or further manufacturing).
FDA framing
Under Part 1271 our products are not HCT/Ps; they are precursors to the HCT/Ps customers make. Labeled “For manufacturing use only. Not for direct human use.” Manufactured under GMP, Part 1271 Subparts A–C and applicable Subpart D provisions.
EU framing
Also manufactured under EU Directives 2004/23/EC and 2006/17/EC, with Discovery as Procurement Organization and the customer as Tissue Establishment. BM and LP products are classed as peripheral blood stem cells under 2004/23/EC and 2001/83/EC.
| Registration / license | Identifier |
|---|---|
| FDA registration | 3010226283 |
| CA DPH Tissue Bank License | CTB 00080812 |
| CA DPH License for Production of Biologics | Blood Bank ID 9732 |
| CLIA Certificate of Compliance (Alameda) | 05D2069499 |
| CLIA Certificate of Compliance (Quincy) | 22D2126670 |
| Medical Director + independent IRB-approved consent | In place |