TABLE 3.
The representative documents and standards developed by other standards development organizations in addition to ISO
| SDO | Documents/standards |
|---|---|
| ASTM International | ASTM F2997‐21 Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis |
| AABB | Standards for Cellular Therapy Services (10th Edition) |
| ASTM International | ASTM E3231‐19 Standard Guide for Cell Culture Growth Assessment of Single‐Use Material |
| ASTM International | ASTM F3163‐16 Standard Guide for Classification of Cellular and/or Tissue‐Based Products (CTPs) for Skin Wounds |
| ASTM International | ASTM F3368‐19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products |
| ATCC | ASN‐0002‐2011 Authentication of Human Cell Lines: Standardization of STR Profiling |
| BSI | PAS 93:2011 Characterization of Human Cells for Clinical Applications. Guide |
| EDQM | EP 2.7.23 Numeration of CD34/CD45 + Cells in Haematopoietic Products |
| EDQM | EP 2.7.29 Nucleated Cell Count and Viability |
| EDQM | EP 5.2.12 Raw Materials of Biological Origin for the Production of Cell‐Based and Gene Therapy Medicinal Products |
| FACT | FACT Common Standards for Cellular Therapies (Second Edition) |
| FACT | FACT Standards for Immune Effector Cells (First Edition, Version 1.1) |
| FACT | FACT‐JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, & Administration (Eighth Edition) |
| ISCT | Minimal Criteria for Defining Multipotent Mesenchymal Stromal Cells. The International Society for Cellular Therapy Position Statement |
| ISCT | Potency Assay Development for Cellular Therapy Products: An ISCT Review of the Requirements and Experiences in the Industry |
| ISCT | Stromal Cells from the Adipose Tissue‐Derived Stromal Vascular Fraction and Culture Expanded Adipose Tissue‐Derived Stromal/Stem Cells: A Joint Statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT) |
| PDA | TR 81 Cell‐Based Therapy Control Strategy |
| PMDA | MHLW No. 1314 Guidelines on Ensuring the Quality and Safety of Products Derived from Processed Human Stem Cells |
| PMDA | MHLW No. 266 General Principles for the Handling and Use of Cellular/Tissue‐Based Products |
| PMDA | MHLW Notifications: Autologous No. 0208003, Allogenic No. 0912006 Guidelines on Ensuring Quality and Safety of Products Derived from Processed Cell/Tissue |
| USP | 41‐ NF 36 (1044) Cryopreservation of Cells |
| USP | USP <1043> Ancillary Materials for Cell, Gene, and Tissue‐Engineered Products |
| USP | USP <1046> Cell and Gene Therapies Products |
| USP | USP <127> Flow Cytometric Enumeration of CD34 + Cells |
Abbreviations: ATCC, American Type Culture Collection; BSI, British Standards Institution; EDQM, European Directorate for the Quality of Medicines; FACT, Foundation for the Accreditation of Cellular Therapy; ISCT, International Society for Cellular Therapy; PDA, Parenteral Drug Association; PMDA, Pharmaceuticals and Medical Devices Agency, Japan; USP, United States Pharmacopeia.