Downloads

1. Developing Your Vapor Phase Hydrogen Peroxide Cycle 11/10/2026

   Vapor phase hydrogen peroxide has been used for decades as a surface decontaminant in pharma/biotech, but there has been little guidance on how to establish the parameters. Here's an industry consensus from BioPhorum.

2. Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review 11/6/2026

   Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.

3. What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI 11/4/2026

   The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

4. How Should We Measure The True Potency Of RNA Therapeutics? 10/5/2026

   An RNA therapeutic can generate a strong molecular signal without producing the intended biological function. Let's look at how best to predict whether the RNA has completed its task.

5. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

6. What FDA Inspectors Want From Your OOS File 9/16/2026

   Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

7. A QMS That Anticipates Cell And Gene Therapy Quality Challenges 9/2/2026

   Some quality system elements are non-negotiable in Phase 1 cell and gene therapy. For the rest, a risk matrix can help define flexible, defensible specifications.

8. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

   The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

9. Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring 7/22/2026

   Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

10. Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches 7/14/2026

    This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies.