DIN/ISO mirror committee “Biotechnology” holds web conference

In late April, the national mirror committee to the international standards committee ISO/TC 276 Biotechnology met in a web conference. The convenors of the Working Groups “Terminology”, “Biobanks and bioresources”, “Analytical methods”, “Bioprocessing”, and “Data processing and integration” reported on national standardisation activities. The WG “Terminology” continues to coordinate the definition of standards across all working groups. In addition, standardisation work on “ISO 5058-1:2021 Biotechnology – Genome editing – Part 1: Vocabulary” was completed and the standard was published.

The WG “Biobanks and bioresources” has the following projects in progress:

  • Biobanking – Requirements for human mesenchymal stromal cells derived from bone marrow
  • Biobanking – Requirements for human and mouse pluripotent stem cells
  • Biobanking of microorganisms – Part 1: Bacteria and archaea
  • Biobanking – Requirements for the biobanking of plant biological material for research and development
  • Biobanking – Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

The WG “Analytical methods” is currently working on the following projects:

  • Minimum requirements for optical signal measurements in photometric methods for biological samples
  • Nucleic acid synthesis – Part 2: General definitions and requirements for the production and quality control of synthesized gene fragment, gene, and genome
  • Minimum requirements for cellular morphological analysis – Image capture, image processing, and morphometry
  • Analytical methods – Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
  • General requirements and considerations for cell line authentication

The WG “Bioprocessing” has almost completed the review of its first project “Ancillary materials present during the production of cellular therapeutic products and gene therapy products”. Here, three former standards have been consolidated into one revised standard. In addition, work has been intensified on the project “Bioprocessing – General requirements for the design of packaging to contain cells for therapeutic use”.

The participants also discussed preparations for the next Working Group meetings. The plenary session of ISO/TC 276 Biotechnology will convene again in November 2022.

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