Clinical Supply Manufacturing Articles

  1. The Most Difficult Outsourcing Tasks 9/6/2023

    Hint: According to long-termed Pfizer supply-chain professional Francis Dumont, it is sterile-fill. Learn about that and much more on working effectively with CDMOs to optimize production.

  2. 7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing 9/11/2019

    Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.

  3. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

    The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.

  4. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

  5. 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.

  6. FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

    This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.

  7. New Guide Tackles Best Practices For Making Allogeneic Cell Therapies 6/3/2024

    The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into some of the bigger themes in its recent guide.

  8. 5 Benefits Of Using MES For Cell & Gene Therapies 12/20/2024

    Cell and gene therapies have unique complexities and challenges. A manufacturing execution system (MES) can expedite your processes and get your product to commercialization faster.

  9. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  10. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.