Detection of Impurities Related to Biopharmaceutical Processes
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Ongoing, First published Jun 08, 2023
Biopharmaceutical impurities can be divided into two categories: extraneous contaminants and product-related impurities. Extraneous contaminants include microbial contamination, pyrogens, cellular components, components in culture media, substances from various steps in the production process, and substances from purification steps, etc. Various impurities and quantities will affect the safety of the final drug, and the identification, quantification, qualitative and control and removal of impurities are very important in the development process. Common biopharmaceutical impurities include: Protein A, G and L residues; double-stranded RNA (dsRNA) residues; host DNA residues; BSA residues; CHO host protein (HCP) residues.
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