Clinical Supply Manufacturing Articles

1. The 4 Technologies Poised To Transform The Pharmaceutical Supply Chain In 2025 And Beyond 12/2/2024

   These key technological advancements will significantly impact the pharma/biotech supply chain in 2025 and beyond. If you aren't implementing any of them yet, you may want to rethink your plans.

2. 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.

3. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

   The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

4. Digitizing CMC Knowledge Management 4/8/2024

   Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.

5. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

   Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.

6. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

   The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

7. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

   Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

8. Process Development With “The End In Mind” For Startups 3/20/2024

   We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

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. Green Gains In Biopharma Without Closing Facilities? 2/29/2024

    Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.