Global cGMP Manufacturing Sites

 

United States and Japan Facilities

Cell therapy products are unique — they require specialized facilities, expert personnel and dedicated resources to efficiently support clients' development and manufacturing needs.

With more than 55,000 square feet of development and manufacturing space, the PCT service platform offers globally harmonized GMP-compliant cell therapy manufacturing infrastructure. With facilities on both the east and west coasts of the United States, as well as a newly constructed facility in Yokohama, Japan (expected to open in April, 2018), PCT clients enjoy ideal geographic coverage, access to North American and Asian markets, and redundancy capabilities to mitigate risk.

Features of our controlled environment rooms (CERs or cleanrooms) include:

  • ISO designation 7 classification (with some ISO 6 classification space for cell therapy production with EU compliance)

  • ISO designation 8 gown-in/gown-out rooms

  • Unidirectional-flow

  • Negative-pressure

  • Material pass-throughs

  • Controlled access

  • Live facility and equipment monitoring with automated alarm call-out

  • Dedicated HVAC systems

  • Uninterruptible power supply (UPS) connection maintained by an external generator

cGMP Compliant

All of our GMP-compliant facilities offer 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 U.S. facilities are 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. Our Yokohama facility is designed for compliance with Japan PMDA requirements.

PCT Allendale Facility

PCT Allendale in Allendale, New Jersey is a 30,000-square-foot, GMP-compliant facility currently being expanded to house our growing operations, including expanding our capability to produce EU-compliant cell therapy products. 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 commercial cell therapy manufacturing, including large-scale fill/finish operations.

The existing facility, housing six clean rooms, will be renovated for improved process flow and commercial infrastructure with completion of these upgrades expected by the end of April 2018, with facility validation by the end of June 2018. 

PCT Allendale is being expanded to include a new 49,700 square foot facility which will house additional Grade B/ISO 7 controlled environment rooms, HCATS’ Center for Innovation and Engineering, manufacturing development labs, quality control and microbiology labs, warehousing and executive offices. By the end of October 2018, 1,200 square feet of controlled environment rooms, 3,800 square feet of classified support areas, and additional support areas will be constructed with facility validation complete by the end of 2018. 

For more information on these capacity expansions, please read the press release

PCT Allendale is within close proximity to LaGuardia, JFK and Newark airports.

 

PCT Mountain View Facility

PCT Mountain View in Mountain View, California is a GMP-compliant, 25,000-square-foot cell therapy manufacturing facility with approximately 12,500 square feet of manufacturing operations space, 12,000 square feet of office space, ample capacity for projects in all stages of development ranging from process/product development to commercial cell therapy manufacturing, including fill/finish operations.  

PCT maintains a California Drug Manufacturing License for the conduct of clinical trial manufacture and distribution of cell-based products. The facility also houses corporate offices for our California-based team.

PCT Mountain View is within close proximity to airports in San Francisco, Oakland and San Jose.

Yokohama, Japan

Construction Completed

Validation of facility to begin client manufacturing expected to complete by April 2018