ISO 20399:2022 PDF

Overview

ISO 20399:2022 - "Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products" defines requirements and guidance for ancillary materials (AMs) used in cell and gene therapy manufacturing. It applies to materials that contact the active substance during cell processing but are not intended to form part of the final product (e.g., reagents, cytokines, growth factors, enzymes, serum, culture media, coated dishes, beads, cryoprotectants, plasmids, viral vectors). The standard clarifies responsibilities for AM suppliers and AM users and promotes a risk‑based approach to ensure consistency, safety and quality.

Key topics and requirements

• Definitions and scope - Clear definition of AMs and exclusions (e.g., starting cells, final product components, routine non-biological consumables).
• Strategy and responsibilities - Roles of AM suppliers and users, qualification expectations and mutual information exchange.
• Qualification and evaluation - Criteria for AM selection, characterization, lot‑to‑lot consistency and supplier assessment.
• Animal‑derived components & biosafety - Considerations for animal/human‑derived materials and viral inactivation strategies.
• Risk mitigation - Scientific approaches, supplier audits, questionnaires and formal risk assessments.
• AM characteristics - Identity, purity, impurities, stability, storage conditions and traceability requirements.
• Manufacturing controls - Quality management systems, manufacturing process information, container/closure considerations.
• Performance & testing - Expectations for performance assays, qualification activities and interpretation of results.
• Documentation - Requirements for Certificates of Analysis, certificates of origin/compliance/irradiation and reporting.
• Change management - Managing and communicating changes to AM components; decision chart in Annex A plus supporting annexes for workflows and characterization.

Applications - who uses ISO 20399:2022

• AM suppliers - to define documentation, testing, lot control and supplier declarations that meet user needs.
• Cell and gene therapy manufacturers / CMOs / CROs - to qualify and manage AMs, ensure lot‑to‑lot consistency and support product quality.
• Quality assurance & regulatory affairs - for audit evidence, supplier oversight and alignment with a risk‑based control strategy.
• Laboratory operations and process development - to select appropriate AMs, design performance assays and establish stability/storage practices.
• Auditors & inspectors - to assess compliance and traceability of AM-related controls.

Related standards and notes

• Prepared by ISO/TC 276 (Biotechnology). Normative reference includes ISO 8601‑1 (date/time representations).
• ISO 20399 complements existing cell and gene therapy process standards and national/regulatory requirements - users should consider applicable regulations in addition to this standard.

Keywords: ISO 20399:2022, ancillary materials, AMs, cell and gene therapy, lot-to-lot consistency, qualification, biosafety, risk-based approach, certificate of analysis, supplier audit.