Validation, Commissioning & Design Featured Articles

  1. Adapting To Evolving Needs: How Modular Cleanrooms Enhance Safety In Pharmaceutical Manufacturing 6/9/2026

    High-potency therapies demand stringent containment and worker safety. Discover how scalable, modular infrastructure simplifies compliance and protects product integrity in regulated facilities.

  2. Closing The QC Gap For mAbs: Rapid Answers Without Compromising 6/9/2026

    Monoclonal antibodies are complex biologics requiring precise analytical strategies to monitor critical quality attributes and impurities, with molecular assays like qPCR supporting sensitive detection, product integrity, and regulatory compliance.

  3. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

  4. How Automation Helps Life Sciences Manufacturers Deliver Faster, Safer Therapies 6/2/2026

    Automation paired with smart data management is becoming the base for faster drug and vaccine production without trading away quality. Five investment priorities show where manufacturers are concentrating their efforts.

  5. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

  6. Why Cloud Migration Is The Key To Business Agility 5/31/2026

    Discover how transitioning to cloud-native architectures drives business agility in biopharma, reducing infrastructure costs, minimizing downtime, and accelerating time to market for novel therapies.

  7. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

  8. Simulating PUPSIT Or Gas Purges In Bacterial Challenge Tests 5/22/2026

    Managing PUPSIT‑related risks is a critical part of contamination control. Learn how bacterial retention studies, wetting fluids, and downstream practices influence sterility assurance.

  9. Product-Wet Integrity Testing: Risk-Based Strategies 5/22/2026

    When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

  10. If Compliance Is Slowing You Down, Your Regulations Are Not The Problem. Your Model Is. 5/22/2026

    Compliance friction stems from fragmented operational systems rather than regulatory standards. Unify lifecycle traceability to maintain continuous audit readiness and speed time to market.