Novel manufacturing process, supported through to phase 2a

The sponsor was planning a clinical trial with an investigational medicinal product manufactured using a complex, novel process. Manufacture runs through several stages with numerous manual steps. The sponsor needed an experienced partner to ensure GMP-compliant manufacture and to release the investigational medicinal product for use in the trial. In addition, the multi-stage process was to be converted into a new process that could be automated while remaining GMP-compliant.

We oversaw the GMP-compliant manufacture of the investigational medicinal product and qualified the manufacturers through audits. We reviewed the data and documents to check whether they met the regulatory requirements for conducting a clinical trial. We prepared the IMPD and supported the submission of the clinical trial application in several countries. We released the investigational medicinal product for use in the trial in several European countries. We also advised the sponsor on developing a novel, fully automated and GMP-compliant manufacturing process.

The phase 2a clinical trial went ahead. GMP oversight, batch release and regulatory support came from a single provider. The complex, multi-stage process with many manual steps was converted into a GMP-compliant, fully automated process. Production time fell from months to a few hours.