Cell therapy products are unique — they require specialized facilities, expert personnel, and dedicated resources, to efficiently support Clients' development and manufacturing needs.
With over 55,000 square feet of development and manufacturing space, PCT is the only GMP-compliant cell therapy contract development and manufacturing organization (CDMO) with facilities on both the East and the West Coasts of the United States.
Our controlled environment rooms (CERs) or clean rooms are unidirectional-flow, negative-pressure, ISO designation 7/ Class 10,000 classified, with ISO designation 8/ Class 100,000 gown-in/gown-out rooms, and material pass-throughs. Each CER has controlled access, live facility and equipment monitoring with automated alarm call-out, dedicated HVAC systems, and is on an uninterruptible power supply (UPS) connection maintained by an external generator.
Each GMP-compliant facility also contains cell and tissue cryogenic storage rooms with controlled access; live facility and equipment monitoring with automated alarm call-out; and UPS connection, ensuring the highest level of quality control and risk mitigation for product storage.
In addition to CERs and cryostorage rooms, our facilities house GMP-compliant material management facilities, QC and analytical laboratories, as well as product and process development laboratories.
Our facilities are AABB- and FACT-accredited, hold all requisite licensures, are registered with the FDA as human cells, tissues, and cellular and tissue-based products (HCT/Ps) facilities, and maintain GMP -compliant quality systems.
Allendale, New Jersey
The Allendale facility is PCT's newest facility. The 30,000 square foot GMP-compliant facility provides ample capacity to house PCT's growing operations. With approximately 1,300 square feet of CERs to support PCT's existing and future Clients, the Allendale facility offers capacity for projects in all stages of development ranging from process/product development to Phase 3 clinical trials, including large scale fill/finish operations, and commercial cell therapy manufacturing.
The GMP facility has been designed to be compliant with the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) standards for the manufacture of human cells for therapeutic use. The facility also houses PCT’s corporate headquarters.
Mountain View, California
PCT’s Mountain View facility is a GMP-compliant, 25,000 square foot cell therapy manufacturing facility, with approximately 2,000 square feet of CER space and ample capacity for projects in all stages of development ranging from process/product development to Phase 3 clinical trials, including large scale fill/finish operations, and commercial cell therapy manufacturing. The facility also houses corporate offices for our California-based team.
PCT maintains a California Drug Manufacturing License for the conduct of clinical trial manufacture and distribution of cell-based products, and our Mountain View facility is compliant with FDA standards for the manufacture of human cells for therapeutic use.