Clinical Supply Manufacturing Articles

1. Multiplying Forces Of Clinical Supply Outsourcing 1/30/2023

   There are a number of varying and converging forces baring down on sponsors looking for CROs/CDMOs who can provide a full slate of services around their clinical-trial material. Both CDMOs and sponsors need to add or subtract from their strategies to adjust.

2. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

   Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.

3. 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.

4. 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.

5. Exploring Sanofi R&D's Batch Monitoring Initiative 10/23/2024

   The project established predictability during testing and release for the production of medicine to support clinical trials.

6. 3 Strategies For mAb Manufacturing: How Do You Choose? 3/19/2025

   As cost and supply come under more scrutiny, there are primarily three scaling strategies for mAb manufacturing that can be leveraged, each with its own set of pros and cons.

7. How To Minimize The Impact Of Stability Testing On Gene Therapy Batch Yield 8/27/2024

   This article outlines strategies for reducing the volumes required for gene therapy stability studies, with the goal of conserving product for patients, while remaining compliant and delivering data on CQAs. 

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. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

   In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

10. 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.