Validation, Commissioning & Design Featured Articles

  1. A Scalable Analytical Method For Quality-Driven AAV Characterization 7/1/2026

    AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

  2. Step Into The Future Of Chromatography Automation 7/1/2026

    As downstream processing grows more connected and complex, chromatography remains a key automation challenge. See how greater flexibility and stronger control are shaping more practical workflows.

  3. Designing For cGMP Compliance: Facility Requirements And Best Practices 6/26/2026

    Integrating process flows, HVAC controls, and cleanability during initial cleanroom planning ensures cGMP compliance and mitigates long-term contamination risks.

  4. Q&A: From Trial-And-Error To Predictive Protein Production 6/26/2026

    Speed in protein production starts with better inputs and stronger process analytics. Learn how a three-part strategy helps teams reduce rework and move from guesswork to predictable outcomes.

  5. Scientific Data Is Not AI‑Ready By Default 6/26/2026

    Convert siloed laboratory data into trusted, AI-ready assets. Learn to enforce data integrity principles at the point of origin to streamline analytics and reduce GxP compliance risks.

  6. Pharmaceutical Technology Transfer Steps 6/26/2026

    Streamline pharmaceutical technology transfer by following a structured, multi-step framework. Learn to mitigate operational risks, maintain process validation, and ensure regulatory compliance.

  7. CMC (Chemistry, Manufacturing and Controls) Management 6/26/2026

    Eliminate regulatory risks caused by fragmented data. Learn how a continuous data thread from bench to batch streamlines tech transfer and accelerates filing timelines.

  8. Glove Integrity Testing: Changes In EU GMP Annex 1 6/25/2026

    EU GMP Annex 1 now defines clear expectations for glove integrity testing. Examine how reliability, efficiency, and equipment usability are becoming essential factors for maintaining compliance.

  9. The Alternative Solution To Comply With The New GMP Annex 1 6/25/2026

    Rising Annex 1 demands are pushing facilities to rethink contamination control. See how RABS retrofits offer a practical path to compliance, combining effective containment and faster implementation.

  10. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.