Manufacturing >

PCT is an industry leader in the contract manufacture of cell therapy products.

From the very beginning we help you develop and grow with commercialization in mind, leveraging our unprecedented cell therapy-focused experience to ensure maximum cost-effectiveness, regulatory compliance and timeliness-to-market.

Our Manufacturing Solutions

We assist our Clients in overcoming intrinsic cell manufacturing challenges, including:

  • Substantial capital and resource commitments
  • Limited unit size
  • Short turnaround time between collection and delivery
  • Product characterization
  • Limitations of manufacturing infrastructure, personnel, and investment capital
  • Process scalability
  • Increasingly stringent regulatory requirements

Our Quality Systems Approach

We use a Quality Systems approach that ensures cGMP/GTP compliance in critical areas including:

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