Overview
ISO 24651:2022 - "Biotechnology - Biobanking - Requirements for human mesenchymal stromal cells derived from bone marrow" defines requirements for the biobanking of human bone marrow‑derived mesenchymal stromal cells (hBM‑MSCs) for research purposes. The standard covers the full biobanking lifecycle: collection of bone marrow and associated donor data, isolation, culture and expansion, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. It is explicitly intended for research, R&D and preclinical use and does not apply to clinical in‑vivo therapy, cell therapy or therapeutic applications.
Key topics and technical requirements
ISO 24651:2022 sets out practical, process‑oriented requirements to ensure reproducibility, traceability and quality of hBM‑MSC collections. Major technical topics include:
- General biobank requirements: personnel, facilities, equipment, reagents and consumables, and information management.
- Collection and donor data: documentation of donor information, anatomical site, collection volume and procedure for bone marrow sampling.
- Transport and reception: conditions for safe transfer of bone marrow or hBM‑MSCs to the biobank and reception/traceability procedures.
- Isolation and expansion: controlled processes for isolating hBM‑MSCs (from aspirate or puncture samples), unique sample identification, and testing for infectious agents.
- Characterization assays: viability, morphology, population doubling time, purity, in vitro self‑renewal and proliferation, multilineage differentiation (adipogenic, chondrogenic, osteogenic), immunophenotyping (flow cytometry), secretome assays and immunoregulatory testing.
- Quality control and contamination monitoring: routine QC checks and microbial contamination controls.
- Cryopreservation, storage and thawing: validated procedures for freezing, long‑term storage and recovery of cells.
- Distribution, transport and disposal: information for users, packaging/transport requirements and secure disposal methods.
- Traceability: unique identifiers and robust data management to link samples and associated metadata.
Practical applications and benefits
- Improves reproducibility of hBM‑MSC research across institutions.
- Facilitates data comparability by standardizing isolation, characterization and storage practices.
- Enhances traceability, biosafety and quality control for academic, public and private biobanks.
- Supports reliable sample sharing for preclinical studies and non‑clinical research.
Who should use this standard
- Biobanks and research facilities that collect, process, cryopreserve or distribute hBM‑MSCs for research.
- Academic laboratories, biotech R&D groups and preclinical service providers seeking standardized procedures and documented quality systems.
Related standards
- ISO 20387:2018 - Biotechnology - Biobanking - General requirements for biobanking
- ISO 21709:2020 - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
- ISO 8601-1 - Date and time representations
Keywords: ISO 24651:2022, hBM‑MSCs, biobanking, bone marrow, cryopreservation, cell characterization, quality control, biobank standard.