T/SHPPA 019-2023 Plasmid production quality management guidelines for immune cell therapy product manufacturing

Scope

Scope: This document applies to the production quality management of plasmids used in the in vitro gene modification system for the production of immunocell therapy products; Main technical content: This guide sets clear requirements in terms of institutions and personnel, plant and equipment, production management, material management, bacterial seed batches, process control, quality control, packaging and storage, transportation, etc. Manufacturing enterprises can standardize the production quality management of plasmids in accordance with the requirements of this guide, and further ensure product quality. This guide fills the gap in the production quality management of plasmids used in the in vitro gene modification system for the production of immunocell therapy products in China, and lays a foundation for further improving the regulatory and standard system of cell therapy products.

Development Information

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