Advance the development, manufacturing, and application of next-generation medical therapies with ANSI’s Regenerative Medicine standards packages. These collections bring together key standards for cell therapy, gene therapy, tissue engineering, biomaterials, and biomanufacturing processes that support the production and evaluation of advanced therapeutic products. Covering requirements for product quality, safety, characterization, and clinical translation, these standards are used by researchers, developers, manufacturers, and regulatory professionals working to bring regenerative therapies from the laboratory to clinical application. Whether developing cellular products, engineering biological tissues, or scaling advanced therapies, these packages provide essential guidance for innovation, quality assurance, and consistent practice in regenerative medicine.
CBER Voluntary Consensus Standards Recognized: Cell Characterization Package provides guidance on quantifying cell viability, cell counting and more.
CBER Voluntary Consensus Standards Recognized: Cryopreservation and Storage Package provides guidance on the cryopreservation and storage of cells and genes.
CBER Voluntary Consensus Standards Recognized: Scaffolds Package provides guidance on cell viability within biomaterial scaffolds, tissue engineered scaffolds and more.
CBER Voluntary Consensus Standards Recognized: Sequencing Package provides guidance on nucleic acid sequencing.
Access this comprehensive collection of product quality and characterization tissue engineering standards. Associated standards pending development are:
ISO/DIS 23033
ISO/CD 23511
ISO/WD 24190
ASTM WK17329
ASTM WK51697
ASTM WK59216
ASTM WK62115
ASTM WK65476
ISO 20391-2:2019
ISO/AWI TS 23565
Access guidance standards needed for addressing analytical and testing methodologies for tissue engineering. Associated standards pending development are:
ISO/ TR 3985
ISO/CD 20397-1
ISO/WD 20688-2
ISO/DIS 23033
ISO/WD 24190
ISO/AWI TS 24420
ISO/CD 24421
ASTM WK72274
ASTM WK74668
ISO/AWI TS 24560-1
ASTM WK51697
ASTM WK55364
ASTM WK57514
ASTM WK62115
ASTM WK65476
Access this comprehensive collection of cell therapy standards addressing product quality and characterization. Associated standards pending development are:
STM WK59216
ISO/CD 23511
ISO/AWI TS 23565
ISO/DIS 23033