Clinical Supply Manufacturing Articles

  1. What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish 9/11/2025

    Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.

  2. Solving The Leukopak Supply Chain Issue With Cryopreservation 11/25/2024

    Allogeneic cell therapy developers report an alarming number of starting materials arrive at the wrong temperatures, late, or fail to arrive altogether.

  3. Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products 5/23/2024

    FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.

  4. Compliance, Costs, And Site Readiness In CAR-T Clinical Trials 3/19/2026

    Navigate CAR-T trial complexity: uncover key compliance, budgeting, and site readiness strategies to ensure safe, efficient, and successful patient care.

  5. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

  6. 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.

  7. 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.

  8. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

    AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

  9. Why Do So Few Cell Therapies Make The Leap From Lab To GMP? 11/5/2025

    Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.

  10. New Group Wants 'Phase-Appropriate' Thinking To Retire 9/4/2025

    Decisions in cell and gene therapy are not about aligning with arbitrary clinical phases but about balancing risk.