INSIGHTS ON REGULATORY COMPLIANCE

• Advancing Multiomics Through Intelligent Automation

  Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.

• Modular Facilities With Smaller Footprint Through Dynamic Perfusion

  Discover how a top CDMO leveraged dynamic perfusion technology to boost biomanufacturing throughput, cut capital costs, and enable flexible, multi-modality production.

• Build An AAV8 Platform: Lessons From A Collaborative Development Journey

  Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

• Choosing The Right PCD Configuration For Reliable Sterility Assurance

  Accurate PCD configuration ensures sterility assurance. Learn how to align validation strategies with ISO standards, optimize cycle efficiency, and select the right BI format for EO sterilization success.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  6/12/2025

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• 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.

• Key Considerations For Rapid Microbial Methods For Mycoplasma Detection

  5/29/2025

  Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

• Leveraging Rapid Sterility Testing To Advance Cell Therapy Production

  6/23/2025

  Explore the crucial role of rapid sterility testing in cell therapy manufacturing. This presentation delves into the benefits of swift, accurate detection for product quality and patient safety.

• Avoiding The Pitfalls Of PQR

  10/9/2024

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."