Guest Columns

  1. Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need 6/18/2025

    In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.

  2. What Global Survey Says About Scant Patient Access To CAR-T Therapy 6/17/2025

    The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.

  3. Scaling Up Manufacturing? Here's Why You Need A CMC Specialist 6/16/2025

    CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.

  4. Amgen Bets On Agility In The Age Of AI 6/13/2025

    The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.

  5. Peeling Back The Layers Of Radiolabeled Peptide Production 6/12/2025

    From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

  6. A Look At Elsa, The FDA's New AI Digital Assistant 6/12/2025

    The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.

  7. Navigating Data Management Requirements For Sterile Manufacturing 6/11/2025

    Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

  8. Multispecific Trial Supply Stability Hinges On CDMO Agility 6/10/2025

    Naya's CEO describes the dynamics of producing a complex therapeutic for clinical trials on another continent, and how choice of CDMO plays heavily into that strategy.

  9. The Promise And Challenges Of Cell-Free Protein Systems 6/10/2025

    CFPS use cell lysates or purified enzymes to synthesize proteins. They have emerged as a promising alternative to production with living cells.

  10. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.