Establishing a GMP manufacturing facility for peptide vaccines

A renowned research institution for the development of cancer therapeutics is planning to establish a manufacturing 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 analytics must meet the requirements of the EU GMP Guide. The novel process must be coordinated with the approval authorities for the later submission of clinical trial applications and, ultimately, marketing authorisation.

Assessment and support in clarifying the regulatory framework. Support with the design and qualification of premises and facilities, and development of GMP-compliant manufacturing processes and analytical test methods.

Regulatory classification, project management, qualification and validation, and release from a single source. Delivered by a multidisciplinary team. The project is currently in the implementation phase.