Modern GMP Manufacturing Suites, Pilot Plant, And Supporting Infrastructure
BioCentriq owns and operates facilities that are designed exclusively for cell and gene therapy. All sites are fully equipped with standard equipment to manufacture autologous and allogeneic therapies using both open and closed processes. We have the quality systems and procedures in place to manufacture and release clinical grade material.
Our facilities provide our manufacturing, process development, MS&T and quality teams with the space and equipment they need to conduct tech transfer and manufacturing, and they contain the supporting infrastructure and labs needed for storage, warehousing, analytical method development, quality control testing, and more.
Facilities Designed for Varying Projects & Equipment Platforms
- ISO-7 Certified Clean Room Suites
- FDA Registered Facility
- Robust Quality Systems & Procedures
Facility Details and Specifications
All our facilities are less than three years old. We have four manufacturing suites of different sizes and equipment with open and closed processes for both autologous and allogeneic manufacturing.
Four Clean Rooms Designed for Cell and Gene Therapy
Our GMP Manufacturing suites are fully validated and registered with the FDA and include the following:
- Building Management Systems (BMS) for control of suite temperature and pressures
- Validated Environmental Monitoring System (EMS) for alarm and trending of suite temperature, humidity and pressurization
- Segregated air handlers supporting each suite
- Two to three BSCs and other standard equipment
- Controlled access
- Material pass-throughs
The square footage of our suites is as follows:
- 138 Summit Avenue, NJIT LSEC Building, Newark, NJ - Suite 1: 614 sq. ft.
- 138 Summit Avenue, NJIT LSEC Building, Newark, NJ - Suite 2: 466 sq. ft.
- 7 Deer Park Avenue, Monmouth Junction, NJ (South Brunswick) - Suite 3: 450 sq. ft.
- 7 Deer Park Avenue, Monmouth Junction, NJ (South Brunswick) - Suite 4: 390 sq. ft.
- 7 Deer Park Avenue, Monmouth Junction, NJ (South Brunswick) - Suite 5: ~ 1100 sq. ft. (conceptual design)
Fully Equipped BSL-2 Pilot Plant for Process Development & MSAT
We have approximately 5,000 square feet available to support pilot plant operations including process development, analytical methods development, and tech transfer work. Our upstream capabilities feature a variety of cell expansion technologies from flasks and bench-top bioreactors for adherent and suspension cell culture, to large-scale bioreactors up to 200 liters. We have cell counters and a bioprofiler which facilitate the characterization of ongoing cell cultures. Our analytical equipment enables in-house ddPCR, ELISA, flow cytometry, Uv-Vis spectroscopy, and fluorescence spectroscopy. We possess TFF, TFDF, and chromatography capabilities for downstream processing. Lastly, we count on a team of engineers and scientists that are proficient with all these methods and more, ensuring a smooth transition of your process into our pilot plant.
Quality Control Labs for In-Process and Release Testing
BioCentriq has more than 3,000 square feet of quality control laboratory space available which is used to conduct both in-process and release testing. Contact us to learn more about which tests we perform in-house, and which tests we manage on your behalf and outsource to approved vendors.
Storage and Warehousing
Our storage and warehousing capabilities are designed to perfectly meet the needs of your project. We have on-site temperature controlled storage in all conditions typically required for cell and gene therapy manufacturing. Our equipment and facilities are designed to support ambient, refrigerated and frozen materials. We have fully validated chain of custody (COC) processes and carefully track material through all stages of the process, from receiving it to manufacturing, storing, and transporting the material again. Our storage and warehousing facilities have been audited and are GMP compliant.
Training Laboratories
We have dedicated training space available in our Newark, NJ location. The space can be customized to suit your training requirements. Currently, it includes the following:
- Six BSCs in a mock laboratory environment
- Mock gowning area with benches and mirrors
- Sealers and welders available for use
- Set up and additional equipment can be sourced to suit your needs
- Classroom space with whiteboards and audio-visual support
- Easy access via public transportation and plentiful parking