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Biosimilars pp 173-186 | Cite as

Biosimilars Drug Substance Development and Manufacturing: Effective CMC Strategy

  • Adriana E. ManziEmail author
  • Michiel E. Ultee
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 34)

Abstract

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.

Keywords

Biosimilar development Biosimilar manufacturing Chemistry manufacturing controls CMC 

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.Atheln, Inc.San DiegoUSA
  2. 2.Ulteemit BioConsulting, LLCHillsboroughUSA

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