ISO/FDIS 24603 [Under development]

ISO/AWI 20399 [Under development] | Biotechnology – Ancillary materials present during the production of cellular therapeutic products

Acesse:

https://www.iso.org/standard/79399.html

Situação:

Em andamento

ISO/TS 23565:2021 | Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use

https://www.iso.org/standard/76053.html

Situação:

Publicada

ISO/AWI 20688-2 [Under development] | Biotechnology – Nucleic acid synthesis – Part 2: General definitions and requirements for the production and quality control of synthesized gene fragment, gene, and genome

Acesse:

https://www.iso.org/standard/75852.html

Situação:

Em desenvolvimento

ISO 20391-1:2018 | Biotechnology – Cell counting – Part 1: General guidance on cell counting methods

Acesse:

https://www.iso.org/contents/data/standard/06/88/68879.html

Situação:

publicada

ISO/DTS 22859 [Under development] | Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

https://www.iso.org/contents/data/standard/07/40/74052.html

Situação:

Em desenvolvimento

ISO/AWI 24190 [Under development] | Biotechnology – Analytical Methods – Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses

Acesse:

https://www.iso.org/contents/data/standard/07/80/78060.html

Situação:

Em desenvolvimento