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. 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. 

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. 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.

5. Luxturna Maker Spark Therapeutics' Flexible Platform Approach 8/28/2024

   The company proved the concept by bringing to market its AAV-based gene therapy for an inherited form of vision loss.

6. 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.

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. Strategic Procurement For Emerging Pharmas & Biotechs 2/27/2023

   Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

9. Strategies To Tackle CAR-T Product Challenges 6/24/2024

   This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

10. 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.