De-Risking Tech Transfer: Strategies for Clinical-Stage Biotechs and Biopharmas

WEBINAR

The biotech market faces challenges such as increasing competition, evolving regulatory requirements, and the need for rapid innovation in drug development. In response, as a CDMO, we provide comprehensive solutions that integrate proven technologies and regulatory guidance to support clients. Process fitting and optimization examples include improvements that enhance product quality, boost performance, and reduce costs.

To secure comparability despite changes, a robust strategy is essential, involving thorough analytical testing and proactive risk assessment. By focusing on quality and compliance, we ensure that changes do not compromise the integrity or efficacy of the final product.

In this webinar, you will learn:

• The importance of the initial risk assessment to ensure tech transfer success
• To define the appropriate process strategy based on the client's global CMC strategy
• To set appropriate control points on quality attributes in order to anticipate comparability risk