[Executive Summary] Overcoming Manufacturing Challenges for Accelerated Drug Development

New drugs receiving expedited approval have shorter timelines, which can create unique challenges for development and manufacturing. To keep up with the accelerated development timelines, it is important to define the given drug substance’s attributes clearly to understand how it might affect the quality and stability of the final drug product. Manufacturing a drug within an accelerated timeline is a significant endeavor, and it is important to make sure that the manufacturing process is robust and compatible during commercial manufacturing. The manufacturing approach should not be designed solely around speed. It should be evaluated and selected based on the possibility of different dosage forms, low-risk stability, API variability, and applicability of a large range of drug loads.

Thorough planning is critical to the success of accelerated timelines, especially when it comes to the scale-up processes and post-launch changes. A thorough end-to-end risk assessment is a useful tool for effective tech transfers because it takes into consideration all development phases- from API selection, formulation development, to packaging and distribution.


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