The Analytical Journey Of A Biologic Drug: From Discovery Through Commercialization
In this webinar, SGS experts share their extensive knowledge of the testing required at each stage of biologic drug development, offering insights into overcoming common challenges and ensuring a seamless journey from pre-clinical development to commercial release.
The discussion explores critical steps in the pre-clinical early characterization phase, Phase 1 and 2 testing for various biologic modalities — including characterization, bioassays, and other complex assays — and the specialized testing and regulatory requirements necessary for commercial release.
By watching the webinar, you'll gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and strategies for addressing challenges associated with these approaches. Additionally, the webinar covers compliance strategies, best practices for meeting regulatory requirements, and essential considerations for documentation and reporting.
Don't miss this opportunity to deepen your understanding of biologic drug development and navigate the path to regulatory approval with confidence.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Outsourced Pharma? Subscribe today.