BS ISO 20399:2022 - Page 2

Biotechnology. Ancillary materials present during the production of cellular therapeutic products and gene therapy products. | Status: Current

1 Scope This document specifies requirements and gives guidance to suppliers and users of ancillary materials (AMs) to improve the consistency and quality of AMs of biological (human and animal) and chemical origin used in the production of cellular therapeutic products and gene therapy products for human use. This document is applicable to materials that are used for cell processing and that come into contact with the active substance and that do not intentionally form part of the final cell and gene therapy product.

EXAMPLE 1

Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human or bovine), buffered solutions, culture media, dishes (coated with biological material), beads (coated with biological material), cryoprotectants (agents for cryopreservation), activation agents/reagents, non-mammalian cell (e.g. insect cell, bacterial cell), plasmid, viral vector. This document does not apply to materials that are not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product.

EXAMPLE 2

Cells that are either starting materials, intermediates or final form of a cellular therapeutic product, feeder cells, additives used post bioprocessing, scaffolds, non-biological consumables (e.g. beads, dishes, tissue culture flasks, bags, tubing, pipettes, needles), other plasticware that come into contact with the cell or tissue, apparatus, instruments. A decision flowchart is given in Annex A.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.