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1. 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.

2. 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.

3. 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.

4. 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.

5. AI Has Arrived In Biotech CMC Amid Patchwork Governance 6/3/2026

   AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

6. From Exosomes To Nanodrugs: Advancing Therapeutic Delivery For CNS Repair 6/1/2026

   Exosomes are biological vesicles used for cellular communication that can overcome CNS barriers, delivering therapeutic cargo for CNS and optic nerve injuries.

7. Engineering Repeat-Dose RNA: Engineering Around Immune Recognition In Repeat-Dose RNA Therapeutics 4/30/2026

   Designing repeat-dose RNA means engineering around immune recognition — optimizing payloads, purity, and delivery early to sustain efficacy, tolerability, and durability across multiple administrations.

8. A Novel Co-Tethered Transcription Platform For High-Yield, High-Purity mRNA Synthesis 4/15/2026

   Co-tethered transcription boosts mRNA yield and purity by organizing transcription machinery, reducing dsRNA impurities, and streamlining production for scalable RNA therapeutics.

9. Navigating GMP Biosafety Challenges In ATMP Manufacturing 3/26/2026

   BioPhorum's survey findings reveal a wide variation in how biosafety is managed within GMP environments for viral-based ATMPs, underscoring the need for harmonized guidance.

10. Proteomics Tools: A Resurrection 3/4/2026

    For decades, the evolution of proteomics has lagged. Now, a resurrection is underway. New tools are dismantling limitations, signifying a maturation of systems biology.