Clinical Supply Manufacturing Articles

  1. Defining When To Implement Technologies To Support Commercial Growth 11/20/2024

    Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.

  2. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  3. When In The Product's Life Cycle Does Continuous Manufacturing Make Sense? 2/1/2024

    This overview article takes a look at each product development stage for bio/pharmaceuticals to illuminate when continuous manufacturing can satisfy important business drivers.

  4. Have We Got Novel Drug Production And Compliance Timelines All Wrong? 6/13/2024

    Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

  5. 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.

  6. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

    Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

  7. 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.

  8. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

  9. 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.

  10. 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.