ISO 24603:2022 PDF

Overview

ISO 24603:2022 - "Biotechnology - Biobanking - Requirements for human and mouse pluripotent stem cells" specifies quality and operational requirements for biobanking of human and mouse pluripotent stem cells (PSCs). It covers the full biobank lifecycle: collection of biological source material and associated data, establishment and expansion of cell lines, characterization and quality control (QC), preservation (cryopreservation), storage, thawing, disposal, distribution and transport. The standard is intended for organizations performing PSC biobanking for research and development and explicitly excludes cell lines intended for in vivo human clinical or therapeutic use.

Key topics and technical requirements

ISO 24603 organizes practical requirements around core biobanking activities and governance, including:

• Collection and donor information: requirements for associated donor data (human and mouse), ethical and legal considerations, and informed traceability.
• Facility, personnel and supplies: competency of staff, appropriate facilities and validated reagents/consumables.
• Establishment and expansion: procedures for generating PSC lines, unique identification and cell line master files.
• Characterization and functionality: testing for pluripotency, differentiation potential, population doubling time, genetic integrity and culture stability.
• Quality control and testing: microbial contamination checks, testing for infectious agents and routine QC procedures.
• Preservation and storage: cryopreservation best-practice, storage conditions and inventory management to ensure viability and provenance.
• Thawing, distribution and transport: validated thawing procedures and controlled transport/distribution with required data for end-users.
• Documentation and data management: robust information management, traceability, and record keeping (e.g., cell line master file).
• Annexes: informative guidance on potency comparison, example culture/establishment methods and a QC procedure template.

Applications and who uses this standard

ISO 24603 is used by:

• Biobanks and stem cell resource centers that store and manage human PSCs and mouse PSCs.
• Academic and industry research laboratories generating or sourcing PSC lines for basic research, disease modelling, organoid development and drug screening.
• Quality assurance, laboratory managers and regulatory affairs teams seeking harmonized biobanking standards and reproducible cell line data.
• Suppliers of biobanking services, sample transporters and custodians requiring traceability and validated handling practices.

This standard helps organizations improve reproducibility, protect sample integrity, and manage ethical and legal obligations while facilitating safe exchange of PSC materials for R&D.

Related standards

• ISO 20387:2018 - General requirements for biobanking
• ISO/TS 20388:2021 - Requirements for animal biological material
• ISO 21709:2020 - Process and quality requirements for mammalian cell lines
• ISO 8601-1 (date/time representation) and other ISO/TS documents referenced in ISO 24603

Keywords: ISO 24603, biobanking, pluripotent stem cells, human PSCs, mouse PSCs, quality control, cell line characterization, cryopreservation, stem cell biobank requirements.