Guest Columns & From The Editor

  1. Why You Should Measure Comparability Debt Before Ever Starting A Study 9/17/2026

    When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

  2. 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.

  3. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  4. New USP Guidelines, Standards Address Lentivirus Characterization 9/16/2026

    The United States Pharmacopeia is rolling out new standards and tools to help manufacturers characterize fragile, complex lentiviral vectors.

  5. Inside Kyverna's Autoimmune CAR T Platform Beyond SPS 9/16/2026

    Kyverna's progress suggests that autoimmune CAR T's commercial viability will depend as much on manufacturing readiness and focused indication selection as on its potential to deliver durable, drug-free remission.

  6. Bringing Next-Gen Sequencing To GMP Scale 9/10/2026

    NGS enables broad detection of known and novel viruses in a single assay. Its high sensitivity, specificity, and scalability can meet GMP throughput levels.

  7. Risk Managing Through The Void Of ATMP Visible Particle Guidance 9/8/2026

    Regulators expect cell therapy manufacturers to prove they control for visible particles, but guidance remains notably quiet on the matter. Companies must get creative or risk clinical holds.

  8. Engineering CAR T Cells With mRNA-LNPs: Applying Oncology Learnings To Allergic Diseases 9/4/2026

    Targeted lipid nanoparticles (LNPs) could deliver mRNA encoding a CAR directly to T cells inside a patient with allergic disease. The potential implications extend beyond a single allergic condition. 

  9. The Promise Of MRD-Guided CAR-T Treatment 9/3/2026

    Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.

  10. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

    Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.