ISO 20399 Biotechnology - Testing for Cellular Therapeutic Products and Gene Therapy Products

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 20399 testing. This standard specifies requirements and guides suppliers and users of ancillary materials (AMs) to improve the consistency and quality of Auxiliary materials (AMs) of biological (human and animal) and chemical origin used in the manufacture of cellular therapeutic products and gene therapy products for human use.

This standard applies to materials used for cell processing that come into contact with the active substance and do not intentionally form part of the final cell and gene therapy product.

This standard does not apply to materials not used for cell processing, materials that do not come into contact with the active substance, or materials that intentionally form part of the final cell and gene therapy product.

Auxiliary materials (AMs) refer to materials that come into contact with the cellular therapeutic product during cell processing but are not intended to be part of the final product formulation.

AM can be a complex mix of many components. AMs include, for example, salts, buffers, culture medium, supplements such as growth factors, enzymes, and antibodies for immunopurification. When a material consists of more than one material, such as culture medium, all components are AM. Differences in batch-to-batch compositions may hinder the ability to produce consistent cell and gene therapy products with specified quality characteristics.

This standard provides recommendations and requirements to AM suppliers and AM users to ensure consistent production and performance of AMs. This standard also describes the information that can and may be provided to AM users to demonstrate batch-to-lot consistency of AM regarding identity, purity, storage and stability, traceability, biosafety and performance. In addition, this standard provides recommendations and requirements to ensure that the quality of AMs enables the production of safe and effective end products.

EUROLAB assists manufacturers with ISO 20399 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.