PCT Services: Manufacturing

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

From the very beginning PCT helps clients develop and grow with commercialization in mind, leveraging its exceptional cell therapy-focused experience to ensure maximum cost-effectiveness, regulatory compliance and timeliness-to-market.

PCT’s Manufacturing Solutions

PCT assists its 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

PCT’s Quality Systems Approach

PCT uses 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
NeoStem - Cell Therapy Development - Manufacturing