Biosimilars Drug Substance Development and Manufacturing: Effective CMC Strategy
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The Chemistry, Manufacturing and Controls (CMC) section of a regulatory submission details aspects of the drug’s chemical properties, its manufacturing process development and production, and control mechanisms, including analytical testing both in-process and of the finished drug, to show the process is controlled and reproducible. For a candidate biosimilar much is already understood about the chemistry and properties of the drug by thorough characterization of reference drug product. The challenge is to develop a manufacturing process with adequate controls to ensure that the biosimilar product closely matches the reference drug product and to demonstrate this biosimilarity with a strong analytical package.
KeywordsBiosimilar development Biosimilar manufacturing Chemistry manufacturing controls CMC
- Chaudhari PS, Nath R, Gupta SK. Opportunities and challenges in biosimilar development. Bioprocess Int. 2017;15(5):24–33.Google Scholar
- Gray T. Biosimilar analytical similarity assessments: are you testing sufficient innovator lots? Biosimilar Dev. 2017. https://www.biosimilardevelopment.com/doc/biosimilar-analytical-similarity-assessments-are-you-testing-sufficient-innovator-lots-0001
- Müller-Späth T, Ulmer N, Aumann L, Bavand M. Twin-column cation-exchange chromatography for the purification of biomolecules. Biopharm Int. 2015;28(4):32–6.Google Scholar