Clinical Supply Manufacturing Articles

41. 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. 

42. 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.

43. 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.

44. 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.

45. Beware The Manufacturing Bottleneck: Lessons From Inside 6/6/2022

    Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.” 

46. When Does GMP Matter In Non-GMP Settings? 4/5/2024

    Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

47. Chugai's Race To Zero Emissions At UK4 In Tokyo 6/21/2024

    Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

48. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

49. 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.

50. 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.