##  [ICH Guidelines for CMC Development of Biologics/Biosimilars](/regulatory-radio/ich-guidelines-for-cmc-development-of-biologicsbiosimilars) 

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# 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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