Clinical Supply Manufacturing Articles

1. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

   If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

2. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

   The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

3. 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.

4. 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.

5. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

   At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

6. The Small Biotech's Checklist For FIH Trials 8/27/2024

   Getting medicine to its first patients is enormously complex with many players and moving parts. These are the critical steps.

7. Bridging Preclinical Science And Trial Supply Success 3/27/2026

   Bridging preclinical science and clinical supply ensures therapies reach patients efficiently. Early planning, collaboration, and flexible supply chains prevent costly delays.

8. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

   Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

9. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

   How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

10. Why Clinical Supply Risk Starts With Demand Signals 2/5/2026

    Clinical supply risk often begins long before manufacturing or distribution. Flawed demand signals and enrollment forecasts can quietly create shortages, delays, and costly material waste.