Clinical Supply Manufacturing Articles

  1. 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.

  2. 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.

  3. 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.

  4. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

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    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  6. 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.

  7. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

    This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

  8. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

  9. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

    Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

  10. 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.