Regulatory Videos

  1. Achieving Biologics License Application Success Using A Structured Approach

    This webinar focuses on the critical CMC elements of a product’s life cycle and the regulatory submissions support and strategy necessary for a successful BLA application.

  2. Drug Product Process Characterization For Liquid And Lyophilized DP

    Consider these important initial steps that should be implemented during the process design phase as a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.

  3. Challenges Associated With In-Use Simulated Administration Of Biologics

    Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

  4. Effective Technology Transfer For Mammalian Derived Biopharmaceuticals

    Gain the knowledge and tools necessary to facilitate successful technology transfer and accelerate the translation of your projects from bench to market.