T/SHQAP 001.1-2024 Guidelines for Continuous Manufacture of Biopharmaceuticals Part 1: Raw Materials (Therapeutic Proteins)

Scope

Main technical content: This document proposes the general principles, process research, and production management recommendations for the continuous production of protein stock solutions prepared by engineered cells using continuous manufacturing technology. This document is applicable to the production of protein stock solutions prepared by engineered cells using continuous manufacturing technology, including full continuous production of stock solutions, continuous upstream and downstream production, continuous capture and recycle purification of downstream products, and continuous upstream and batch purification of downstream products; other processes that adopt some related technologies, such as the process of combining perfusion and supplementation with batch cultivation, should be implemented in accordance with the relevant guidelines

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