BIO Deutschland participates in ISO/TC Biotechnology meetings

Standards experts also convened virtually in 2020. This necessitated a departure from the meeting schedule of recent years. Whereas until 2019 the experts met twice a year for face-to-face meetings and were able to exchange ideas intensively over the course of a week, the harmonisation activities of the ISO Technical Committee 276 Biotechnology (ISO/TC 276) were streamlined in 2020. The meetings of Working Groups 1 to 5 were held via web conferences and spread throughout the year. The experts on Working Group 4 “Bioprocessing” met in late November and mid-December for final discussion and coordination in 2020. The Working Group has already developed three standards:

  • Raw materials control for bioprocessing – Part 1: General definitions and requirements for quality control
  • Raw materials control for bioprocessing – Part 2: Best practice guide for suppliers
  • Raw materials control for bioprocessing – Part 3: Best practice guide for developers

These standards will now be compiled in the document “ISO/CD 20399 Biotechnology — Ancillary materials present during the production of cellular therapeutic products”. The revision was a topic at the November meeting. Also discussed was the progress made by the following projects:

  • Biotechnology – General requirements for transportation of cells for therapeutic use (ISO/DIS 21973)
  • Biotechnology – Best practice in raw materials selection in the design of human cell therapy manufacturing processes (ISO/PWI 20404)
  • Biotechnology – Bioprocessing – Management systems for cell processing (ISO/PWI 20406)
  • Biotechnology – General requirements and considerations for equipment systems used in manufacturing of cellular therapeutic products (ISO/WD 23565)

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