Setting up a GMP manufacturing facility for peptide vaccines

A research institution developing cancer therapeutics is planning a facility for the GMP-compliant manufacture of personalised peptide vaccines.

Manufacture takes place in two stages and requires the release of synthetically produced peptides and ATMPs. Premises, equipment, the manufacturing process and analytical testing must meet the requirements of the EU GMP Guide.

The process is novel. It has to be agreed with the competent authorities with a view to later clinical trial applications and, ultimately, a marketing authorisation.

We assess the regulatory framework and help to clarify open questions.

We support the design and qualification of the premises and equipment, as well as the development of GMP-compliant manufacturing processes and analytical test methods.

The institution receives regulatory classification, project management, qualification and validation, and batch release from a single provider. A multidisciplinary team is delivering the project.

The project is currently in the implementation phase.