Episode 2

ICH Guidelines for CMC Development of Biologics/Biosimilars

Episode 2 will detail the various guidelines for biological product development and approval in the market. The reference guidelines discussed in the podcast will include the following:

  • Guidelines that describe the expression construct, cloning, cell bank preparation, and characterization of biological products.
  • Guidelines to be referred for biologics drug substance development and manufacturing.
  • Guidelines to be referred for viral safety evaluation and analytical method validation of the products.
  • Stability management of biological products.

Our Regulatory experts will share more details about the subsidiary guidelines to be referred by a pharma company for streamlining Biologics development.


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