Guest Columns & From The Editor

  1. Full FDA Approval For TECELRA Marks More Than A Regulatory Win For Solid Tumors 7/17/2026

    US WorldMeds' expanded FDA approval for TECELRA represents another important step forward for engineered cell therapies in solid tumors.

  2. Addressing The Particulate Challenge In Cell Therapy Products 7/15/2026

    Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.

  3. Let's Stop Treating Allogeneic Cell Therapy As One Thing 7/14/2026

    Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

  4. Allogeneic Cell Therapy Is Still Learning What Biology Will Allow 7/14/2026

    Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.

  5. 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.

  6. Building CGT Manufacturing Capacity For The Next Commercial Era 7/13/2026

    Recent investments — mostly by CDMOs — are expanding manufacturing capacity to support the growing cell and gene therapy pipeline. We also discuss associated trends and impacts.

  7. Managing The Presence Of Visible Particulates In Cell Therapies 7/10/2026

    Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls. 

  8. FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy 7/9/2026

    Following the FDA approval of TREGZI, Orca Bio's precision engineered allogeneic cell therapy is redefining stem cell transplantation through improved immune control, advanced manufacturing, and a platform designed to expand the future of cell therapy.

  9. Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis 7/8/2026

    Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

  10. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

    In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.