cGMP Manufacturing, Infrastructure and Systems

Our manufacturing capabilities include:

  • ISO 7 and ISO 6 /Grade B cleanrooms across two United States cGMP manufacturing sites (a third facility is under construction and a facility in Yokohama, Japan will open for client manufacture in April 2018)
  • Additional EU compliant Grade B cleanrooms at PCT East
  • Automated and semi-automated fill/finish options (>100 vial capacity per batch)
  • Controlled-rate freezers (seven) for cryopreservation of cell therapy product
  • Experience with cGMP manufacturing for numerous Phase III clinical trials
  • Commercial cell therapy manufacturing readiness in progress

Our cGMP-compliant manufacturing infrastructure includes systems that benefit all clients, such as:

  • Materials, equipment and facilities controls
  • Deviation, Corrective and Preventative Action (CAPA)
  • Change and document controls
  • Validation
  • Auditing (Internal and external)
  • Training

Learn more about cGMP: