cGMP_Manufacturing_Icon.png 

 

cGMP Manufacturing, Infrastructure and Systems

Our cGMP infrastructure delivers a cost-effective approach, ensures regulatory compliance and timeliness-to-market.

 

 

 

Our manufacturing capabilities include:

  • ISO 7 and ISO 6 /Grade B cleanrooms across two bicoastal cGMP manufacturing sites
  • Additional EU compliant Grade B cleanrooms to be brought online 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
New Call-to-action