On-Site Manufacturing In Early Clinical Drug Development (In Europe)

By Suzanne Jansen, MSc, Pharmacist, Early Development Services, PRA Health Sciences; Arjen Akkerman, Msc, Senior Manager, Chemistry, Manufacturing, and Control (CMC) & Qualified Person (QP), Early Development Services, PRA Health Sciences

Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe.

IMP manufacturing can be considered an extension of activities of the clinical team if the IMP is manufactured on site and released based on the analysis performed by an in-house quality control (QC) laboratory. Timelines can be shortened by the technical and clinical teams working in parallel during the start-up phase in early drug development. This allows for quicker Clinical Study Report (CSR) finalization and speeds up progress toward the next stage in clinical drug development.