Clinical Supply Manufacturing Articles

  1. What's A “Hybrid Externalized” Manufacturing Model? 3/10/2022

    Anthos Therapeutics’ phase 2 antibody candidate abelacimab could dramatically improve the way clinicians treat very common, high-risk arterial and venous thromboembolic events. The company is exercising manufacturing creativity to maintain clinical supply. Anthos CEO John Glasspool shares on the Anthos approach to outsourcing. 

  2. Challenges In Manufacturing TIL For Clinical Trials 3/6/2025

    Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.

  3. If The CDMO Shoe Fits, Wear It Now 9/16/2024

    Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

  4. The $122 Billion Question: Can Clinical Trial Supply Systems Keep Pace With Cell Therapy Demand? 5/14/2026

    Cell therapy demand is outpacing manufacturing capacity, forcing clinical supply teams to rethink patient scheduling, production slots, and real-time coordination.

  5. 7 Steps To Accelerate Biopharma Manufacturing Processes 5/21/2024

    Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.

  6. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

    At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

  7. EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence? 6/19/2025

    The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

  8. 4 Tips For Advancing Your AAV Manufacturing Plans 1/4/2022

    Tim Kelly, M.B.A., COO of Homology Medicines, a clinical-stage genetic medicines company, shares four lessons his company learned from building a GMP facility and testing and optimizing their novel platform.

  9. Green Gains In Biopharma Without Closing Facilities? 2/29/2024

    Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.

  10. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

    This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs.