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GMP Clinical Manufacturing

Production of Drug Product/Drug Substance for Use in Clinical Trials

High Quality, Efficient, Reliable, Cross-Functional Manufacturing

BioCentriq owns and operates facilities that are designed exclusively for cell therapy manufacturing. 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 drug product. Our facilities provide end to end, in-house GMP capabilities to complement our Process and Analytical Development Laboratories to ensure smooth transfer and cross functional alignment throughout your products lifecycle. Our GMP manufacturing team are experts at producing high quality, drug products. The cross-functional teams consist of qualified aseptic operators who have years of experience in biologic manufacturing and have been trained and onboarded for drug product manufacturing.

Why Choose BioCentriq?

Our hybrid model allows you to observe or work alongside our operators.

BioCentriq's in-house training team develops skilled and qualified operators.

Our global vendor relationships are leveraged to address supply chain challenges.

ISO-7 Certified Clean Room Suites

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 Therapy Manufacturing

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:

Newark, NJ - Suite 1: 614 sq. ft.
Newark, NJ - Suite 2: 466 sq. ft.
Monmouth Junction, NJ - Suite 3: 450 sq. ft.
Monmouth Junction, NJ - Suite 4: 390 sq. ft.
Monmouth Junction, NJ - Expansion space: 11,000 sq. ft.

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, and flow cytometry. 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.

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.

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.

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: