Validation, Commissioning & Design Featured Articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. A Practical Guide To Autologous CAR T Manufacturing 6/19/2026

   Early process decisions shape scalability, consistency, and compliance in autologous CAR T manufacturing. Learn where variability emerges across the workflow and how to plan ahead.

9. The Invaluable Asset Driving Advanced Therapies Forward 6/19/2026

   Cell therapies are advancing rapidly, but manufacturing delays still limit patient access. Improving operational understanding, reducing risk, and strengthening collaboration may be just as critical.

10. A Custom Path To The Clinic: Inside A Collaborative Model 6/19/2026

    Balancing speed, compliance, and control is no small task. A different approach to external support is emerging—one that prioritizes knowledge transfer, collaboration, and long-term confidence.