Clinical Supply Manufacturing Articles

  1. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  2. 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.

  3. Challenges And Opportunities Of Outsourcing Biopharma Development 2/19/2025

    Oversight, knowledge management, and operational/compliance risk make up the three key challenge classifications to consider when approaching a new outsourcing agreement.

  4. 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.

  5. Strategies To Tackle CAR-T Product Challenges 6/24/2024

    This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

  6. Improving Governance And Compliance With Knowledge Management 4/23/2024

    Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.

  7. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

  8. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

    Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

  9. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  10. On The Potency Assurance Journey, Travelers Need A Road Map 11/13/2025

    When regulatory expectations change by the phase, the route can be difficult and confusing to navigate for both new and experienced potency investigators.