Objective
Creating an in-house GMP-compliant manufacturing capability for a small biotech startup in order to fully leverage the technological platform developed by the firm
Outcome
- Recruitment of a small team integrating the various capabilities: quality assurance, quality control, engineering and production
- Design and procurement of the required utilities and equipment; selection of the site in which to deploy the facility
- Implementation of a GMP-compliant quality system
- Internal transfer of the process from R&D status to GMP-compliant status
- Successful production of clinical batches of drug substance
- Obtention of the GMP Certification for this unit