Strategies for Host Cell Protein Analysis
BIOPHARM-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT(2000)
摘要
Developing methods to detect and measure host cell protein contamination in biopharmaceuticals is technologically complex. A rational, analytical quality control strategy requires focusing on preparation of the immunogen used to generate the antibodies, purification of the antibodies, calibration of the assay, and combining both generic and specific immunoassays to ensure product safety.
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