MilliporeSigma Webinars

  1. The Proof Is In The Pudding: Bacterial Retention Of Sterilizing Grade Membranes 3/27/2017

    While the theoretical foundation of microbial retention by sterilizing grade membrane filters has not changed, advances in technology allow us to better understand the mechanisms and predict its performance. 

  2. Excipient GMP: The Industry Journey From Guides To Standards 8/9/2016

    During this webinar you will learn about the evolution of excipient GMP from guides to standards. A review of the current excipient GMP standards will be covered; specifically, it will include an explanation of what the EXCiPACT™ certification scheme is and how it includes a standard for excipients. Additionally, a review of the currently published NSF/IPEC/ANSI 363 GMP excipient standard will be covered. Lastly, we’ll discuss and review our approach for providing Emprove® documentation to support our customers.

  3. Guideline On Elemental Impurities: Challenges And Approaches For Implementation 8/9/2016

    This webinar provides an overview of the current and upcoming regulatory requirements for elemental impurities, including recent developments in the pharmacopoeias (Ph. Eur. and USP). We will discuss their impact on drug product and pharmaceutical starting materials, focusing on APIs and excipients. The presentation will also outline risk-based approaches to assess and implement control strategies for elemental impurities, based on the latest regulatory requirements, and how this can be supported with dedicated documentation.

  4. Viral Clearance - Something Went Wrong, What Do I Do Now?

    Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

  5. Similar Enough Product Characterization To Support Process Changes And Biosimilar Development

    Characterization is essential to understand the impact following process changes and successful biosimilar development. Here, we provide best approaches for comparability studies.

  6. Smart Bioprocess Data Utilization For Advanced Analytics And Monitoring With Data Analytics Tools Purpose-Built For Bioprocessing

    We share our experience working with organizations as they adopt solutions for automated data acquisition, aggregation, visualizations, and statistical analysis.

  7. Process Impurities: Don't Let PEI Or HCP Derail Your Biotherapy

    Learn product characterization strategies to de-risk manufacturing and detect and characterize host cell proteins and polyethylenimine in mAb and cell and gene therapies.