Regenerative Medicine Standards in Development Updates: ISO
In June 2019, SCB Senior Technical Program Manager Dawn Henke attended the ISO / TC 276 Biotechnology meeting in Tokyo. Below are key highlights from the meeting.
SCB-Coordinated ISO Standard Projects
ISO/AWI 24190: Risk Based Approach for Design and Validation of Methods for Rapid Microbial Detection in Bioprocesses (SCB-coordinated project): Accepted as an approved work item (AWI). The revised draft is expected to go for comments in September, undergo additional revisions, and be submitted for committee draft (CD) ballot in December.
ISO/AWI TS 23565: General Requirements and Considerations for Equipment Systems Used in Manufacturing of Cellular Therapeutic Products (SCB-coordinated project): Comments on the current draft were discussed at the meeting. The standard will be revised and is expected to be submitted for Draft International Standard (DIS) ballot in December.
ISO/CD 23033: General Guidelines for the Characterization of Human Cells for Therapeutic Applications (SCB-coordinated project): Comments received during CD ballot were discussed at the meeting. The standard will be revised and is expected to be submitted for a comment period in December. The timeline for ISO/CD 23033 was extended to a 46-month development period.
ISO/DIS 21973: General Requirements for Transportation of Cells for Therapeutic Use (SCB-coordinated project): Comments received during CD ballot were discussed at the meeting, and the standard is expected to be submitted for DIS ballot in the near future.
ISO/FDIS 20391-2: Cell Counting -- Part 2: Experimental Design and Statistical Analysis to Quantify Counting Method Performance (SCB-coordinated project): The standard has been approved and is currently being finalized for publication.
Additional In-Development ISO Standards
ISO/NP 23511: General Requirements for Cell Line Authentication: Presented at the meeting and approved as a new project (NP).
Minimum Requirements to Assure Optical Signal Quality of Photometric Methods for Biological Measurements: Received a preliminary work item (PWI) designation.
Minimum Requirements and Points to Consider for Cell Morphology -- Image Capture, Segmentation, and Quantification: Received a PWI designation.
ISO/AWI 20397-1: General Requirements for Massive Parallel Sequencing -- Part 1: Nucleic Acid and Library Preparation: Accepted as an AWI and drafting has begun.
ISO/CD 21560:2019(E): (ISO TC 150/SC 7 TEMPs, N219, Tissue Engineered Medical Products) General requirements of TEMPs: Moved to CD ballot stage.
ISO/DIS 21899: General requirements for the validation and verification of processing methods for biological material in biobanks: This standard has moved to the DIS stage.
ISO/DIS 20688-1: Nucleic acid synthesis -- Part 1: General definitions and requirements for the production and quality control of synthesized oligonucleotides: The standard has moved to the DIS stage.
ISO/FDIS 20395-1: Requirements for Evaluating the Performance of Quantification Methods for Nucleic Acid Target Sequences -- Part 1: qPCR and dPCR: The standard has been approved and is currently being finalized for publication.
SDO committees play a key role in standards development and are made up of volunteers from industry, government, and academia. Learn more about how ISO develops standards and how you can get involved.
Calling All SDOs: Contact SCB if you have any updates on regenerative medicine standards you would like us to share with the regenerative medicine community.