Accelerated early clinical manufacturing

The acceleration of early drug development requires Good Manufacturing Practice (GMP) of Investigational Medicinal Product (IMP). IMP manufacturing performed on-site reduces the need for extensive stability programs and simplifies the formulation development. The IMP manufacturing can be adjusted and scheduled based on clinical supply demand of the clinical trial.

IMP manufacturing can be considered an extension of activities of the clinical team if the IMP is developed and manufactured on-site and released based on the set specifications. The analysis of the IMP can be performed by the in-house Quality Control (QC) lab to ensure a quick turn-around of results followed by generation of a Certificate of Analysis (CoA). With shorter timelines, the clinical study report can be finalised earlier, which in turn will help to progress more quickly to the next stage of the clinical drug development plan.

In this whitepaper we will discuss:

• Advantages of accelerated early clinical manufacturing
• EU vs US regulations
• Formulation development
• Quality control and release
• Manufacturing approach