For projects nearing commercialization or for peptide-based drugs already launched, Peptisyntha can handle the project in a pilot plant (with a scale-up factor of 3-5 compared to the kilolabs) or dedicate a specific commercial production suite.

At this stage, Peptisyntha is supporting the project with a full range of services including :

• the preparation and conduct of quality audits and inspections, in particular inspections from regulatory authorities
• the supply of commercial bulk peptide quantities, according to schedules defined and, if required, regularly updated with the customer
• any kind of re-validation which would become necessary as a result of further production scale-ups, implementation of process or method improvements, or any other change that would affect the validated process in place.     
• the revision of the DMF, as required