Clinical Supply Manufacturing Articles

1. How To Turn Your Clinical Supply Chain Pandemic Learnings Into New Best Practices 3/10/2022

   Pivoting, navigating, and problem solving in real time during the pandemic has led to many real-time lessons that have evolved into adapted best practices in the global clinical supply space. This article discusses the new demand curve, packaging operations, IRT considerations, and more.

2. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

   Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

3. 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.

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 FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies 5/24/2024

   This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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

5. 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.

6. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why 11/19/2024

   The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

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. 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.

9. 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).

10. Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship 3/25/2022

    Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.