Guest Columns & From The Editor

  1. Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions? 9/2/2026

    The promise of autoimmune CAR T is enormous, but recent safety pauses from Novartis and BMS underscore why the field needs a more patient-centered approach to risk, clinical outcomes, access, and real-world delivery.

  2. 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.

  3. Using Digital Platforms To Find Your CDMO 9/2/2026

    In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.

  4. July 2026 — CDMO Opportunities And Threats Report 9/1/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  5. ADC CDMO Selection For Small Biotech 8/31/2026

    Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.

  6. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  7. Why Celcuity's REVTORPYK Creates A New Path For Precision Oncology 8/28/2026

    REVTORPYK's FDA approval highlights the broader push toward precision therapies that address complex disease biology, overcome resistance, and deliver more durable patient benefit.

  8. Europe's ATMP Opportunity Still Requires Local Navigation 8/27/2026

    European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

  9. The Unspoken Truth About Cell Therapy Product Understanding 8/27/2026

    Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.

  10. Overcoming Recovery Challenges In AAV Production 8/26/2026

    Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.