Table 1 Standards and GMP literature applicable to cell manufacturing
From: Quality control methods in musculoskeletal tissue engineering: from imaging to biosensors
Standard code/Reference | Standard title/description | Standard status | Standard development stage |
|---|---|---|---|
ISO 20387:2018 | Biotechnology—General requirements for biobanking | Published | – |
ISO/WD TS 22859 | Biotechnology—Requirements for human mesenchymal stem and stromal cells derived from umbilical cord | Under development | Stage 20.20 (Working draft study initiated) |
ISO/AWI 24651 | Biotechnology—Requirements for human mesenchymal stromal cells derived from bone marrow | Under development | Stage 10.99 (new project approved) |
GMP and regulatory elements for MSC production and banking | – | – | |
GMP for iPS | – | – | |
Cleanroom ISO and other regulations | – | – |
