Regulatory Videos

  1. Data Quality & Master Files With Dr. Robert Hariri 9/6/2020

    If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

  2. Inclusion Bodies: Mother Nature's Help Or Hindrance?

    Explore strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

  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.

  5. 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.

  6. Filling The Need For Integrated Bioconjugate Solutions

    Explore how the ADC landscape is being reshaped by new drug product capabilities that enable end-to-end development and manufacturing of cytotoxic bioconjugates.

  7. 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.

  8. Embrace Molecule Complexity With Optimized Expression Technologies

    Explore the needs of more complex candidates, through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.