Overview
ISO/TS 20388:2021 - "Biotechnology - Biobanking - Requirements for animal biological material" provides technical specifications for the responsible handling of biological material obtained from animals (excluding humans). It defines requirements across the biobanking life cycle including collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of animal-derived samples and associated data. Covered resources include solid tissues, fluid samples, cells, excretory products and derived biomolecules (e.g., nucleic acids, proteins, metabolites).
The document is intended for organizations performing biobanking for research and development and is anchored in ethical principles such as the three Rs (Replace, Reduce, Refine). It explicitly excludes material intended for food/feed production, routine food/feed testing laboratories, therapeutic use, and establishment of cell lines derived from animal material.
Key topics and requirements
- Lifecycle management: Requirements for each stage from pre-acquisition planning through distribution and final disposal or destruction.
- Collection practices: Guidance on pre-collection information, collection plans, preparation of containers/consumables, invasive vs non-invasive collection, and specimen-specific methods (blood, tissues, faeces, urine, milk, germplasm).
- Preservation and storage: Principles and conditions for preserving biological integrity of samples and derived biomolecules for research use.
- Transport and reception: Requirements for secure and compliant transport, including associated data handling and chain-of-custody considerations.
- Biosafety and health/safety: Controls to reduce unintentional exposure or release, zoonosis risk management and chemical safety measures.
- Data and documentation: Capture of associated data/metadata, use of material transfer agreements (MTA), and record-keeping to support reproducibility and legal/regulatory compliance.
- Distribution, disposal, destruction: Secure transfer to recipients and irreversible destruction/deletion procedures for both material and associated data.
- Normative and informative annexes: Practical tools such as exemplary data collection tables, collection methods for different animal types and an MTA information checklist; Annex D contains collection/preparation/preservation methods.
Applications and users
Who benefits from ISO/TS 20388:2021:
- Biobanks and sample repositories handling animal material for R&D
- Research institutions and universities that collect and store animal-derived samples
- Veterinary research groups and wildlife/biodiversity biobanks
- Laboratory managers and QA personnel implementing sample lifecycle controls
- Regulatory and compliance teams ensuring ethical, biosafety and legal adherence (including CBD/Nagoya considerations)
Adopting this technical specification helps ensure sample quality, traceability and biosafety, improving reproducibility and facilitating compliant material sharing.
Related standards
- ISO 20387:2018 - Biotechnology - Biobanking - General requirements for biobanking (referenced; implementation basis)
- WHO Laboratory Biosafety Manual, 4th edition (biosafety guidance)
- Relevant national/regional regulations and international agreements (e.g., CBD, Nagoya Protocol)