MilliporeSigma Webinars

1. Purity As A Priority: Optimizing Safety Measures For rAAV Therapies 2/11/2025

   Watch to learn how rAAV vectors in gene therapy are addressing manufacturing impurities, risks to patient safety, and analytical methods for detection while aiding sponsors in regulatory compliance.

2. How To Prevent Protein Aggregation Through Stabilizers And Surfactants 1/13/2025

   Learn about protein aggregation mechanisms, the role of excipients in stabilization, and novel surfactants that prevent aggregation in therapeutic protein formulations in this webinar.

3. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

   Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

4. BioPhorum Raw Materials Risk Assessments 12/19/2024

   Torsten Schaderdorf provides an in-depth exploration of current regulations related to Raw Materials Risk Assessment, highlighting the risk criteria and raw material scope outlined in the BioPhorum guidelines.

5. Assemblies Are Not Particulate Free, Strategies For Risk Mitigation 12/19/2024

   As single-use technologies gain prominence in critical applications, the scrutiny around particulate contamination intensifies due to its potential impact on drug product quality, safety, and patient outcomes.

6. Transforming The Biopharma Supply Chain, eData Solutions For Agility And Manufacturing Efficiency 12/19/2024

   Explore the role of eData in automating processes, enabling predictive analytics, improving supply chain resilience, and adopting standardized digital platforms in biopharma manufacturing.

7. Managing Nitrite Impurities: Supplier-Manufacturer View 12/19/2024

   Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.

8. How Standardized Extractables Data Support E&L Risk Assessment 12/19/2024

   Explore E&L evaluations, USP <665>, supplier-provided extractables data, and collaborative strategies to mitigate risks in Single-Use Systems for biopharmaceutical manufacturing processes.

9. Evaluating USP 665 For Extractables Testing And Reducing Animal Testing For Biological Reactivity 12/19/2024

   Explore evolving compendial methods, USP <665>, and transitioning to cell-based assays for extractables, leachables, and biological reactivity in single-use pharmaceutical manufacturing.

10. Challenges Using Multiple Single-Use Systems Functionality Versus Extractables And Leachables 12/19/2024

    Explore a risk assessment of extractables, evaluating single-use components, and addressing complexities in manufacturing processes, with a case study highlighting compatibility and patient safety concerns.