Implementation of a GMP-compliant internal drug substance manufacturing capability for a startup biotech


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


  • 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