GB/T 47528-2026Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is equivalent to ISO 20399:2022 "Auxiliary substances present in the manufacturing process of biotechnology cell therapy products and gene therapy products".

Auxiliary Materials".

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed and is under the jurisdiction of the National Working Group on Standardization of Bioprocesses (SAC/SWG36).

Introduction

Auxiliary materials refer to materials that come into contact with cell therapy products during cell processing but are not components of the final product.

See Appendix A for the decision diagram.

Auxiliary materials can be complex mixtures of multiple components. These include salts, buffer solutions, culture media, and supplements (such as biological agents).

Examples include growth factors, enzymes, and antibodies used for immunopurification. For substances composed of multiple materials (such as culture media), all components are auxiliary materials.

Batch-to-batch variations in ingredients can affect the ability to produce cell and gene therapy products with specific quality attributes and consistent quality.

Therefore, excipient materials may affect the safety and efficacy of cell and gene therapy products. Proper control of excipient materials is necessary.

It is determined based on risk assessment methods.

This document clarifies the definition of auxiliary materials.

This document provides recommendations and requirements to auxiliary material suppliers and users, aiming to ensure the consistency of auxiliary material production and its performance.

Reliability. This document also details the information available and made available to users to demonstrate the reliability of auxiliary materials in terms of identification, purity, storage and stability.

Batch-to-batch consistency in terms of traceability, biosafety, and performance. Furthermore, this document provides recommendations and requirements to ensure the quality of auxiliary materials.

Quality enables the production of safe and effective final products.

Currently, many standards and guidelines specify the correct handling procedures for cell and gene therapy products to ensure their safety and efficacy.

Sexuality. However, these standards are only indirectly related to auxiliary materials. This document is independent of the standards governing cell processing requirements and is specifically for auxiliary materials.

The issues related to materials were addressed, and the expectations of auxiliary material suppliers and users were clarified.

Biotechnology cell therapy products and gene therapy products Auxiliary materials present in the production process

1 Scope

This document specifies the requirements for suppliers and users of auxiliary materials and provides relevant guidance to improve the production of human cell therapy materials.

Consistency and quality of biological (human and animal) and chemically derived auxiliary materials for products and gene therapy products.

This document applies to materials that come into contact with active substances during cell processing but are not used as components in final cell and gene therapy products.

Example 1.Reagents, anticoagulants, cytokines, growth factors, enzymes, antibodies, serum (human serum or bovine serum), buffer solutions, culture media, petri dishes (coated with biological agents).

Materials), microbeads (coated with biological materials), cryoprotectants (reagents used for cryopreservation), activators/reagents, non-mammalian cells (such as insect cells, bacterial cells) Cells, plasmids, and viral vectors.

This document does not apply to materials not intended for cell treatment, materials not in contact with active substances, or materials intended as final cell and gene therapy products.

The ingredients of the product.

Example 2.Cells, feeder cells, additives used after bioprocessing, scaffolds, and non-cell therapy products as starting materials, intermediates, or final forms of cell therapy products.

Biological consumables (such as microbeads, culture dishes, tissue culture flasks, bags, tubes, pipettes, needles), plastic containers, devices, and instruments that come into contact with cells or tissues.

See Appendix A for the decision diagram.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

ISO 8601-1 Representation for the Interchange of Date and Time Information – Part 1: Fundamental Rules Note. GB/T 7408.1-2023 Representation for the Interchange of Date and Time Information – Part 1: Fundamental Principles (ISO 8601-1:2019, IDT)

3 Terms and Definitions

The following terms and definitions apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.

active substance

A biologically active substance intended for use in cell therapy products (3.9).

Ancillary materials; AM Materials that come into contact with cell therapy products (3.9) during cell processing, but are not part of the final product formulation, excluding branched materials.

Shelves, non-biological consumables, and plastic products.

Note 1.Since excipient materials come into contact with cell therapy products during cell processing, they are crucial to the quality and safety of cell therapy products.

important.

Note 2.The decision diagram in Appendix A illustrates whether a certain material is within the scope of this document.