Novel manufacturing process, supported through to phase 2a

The sponsor of a clinical trial required a partner experienced in the GMP-compliant manufacture of an investigational medicinal product using a complex, novel manufacturing process, to ensure GMP-compliant manufacture. A partner was also required to release the investigational medicinal product for use in the clinical trial. Manufacture of the product is a complex process with numerous manual steps. The multi-stage manufacturing process was to be transformed into a novel, automatable and simultaneously GMP-compliant process.

Oversight of the GMP-compliant manufacture of the investigational medicinal product. Conducting audits to qualify the manufacturers. Review of the data and documents to determine whether the regulatory requirements for conducting a clinical trial were met. Preparation of the IMPD and support with submitting the clinical trial application in several countries. Release of the investigational medicinal product for use in the clinical trial in several European countries. Advice on developing a GMP-compliant, fully automated and entirely novel, multi-stage and complex manufacturing process.

Successful conduct of the clinical trial (phase 2a). Oversight of GMP compliance, batch release and regulatory support from a single source. Successful transfer of a multi-stage, complex manufacturing process with many manual steps into a GMP-compliant, fully automated process. Reduction of production time from months to a few hours.