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Facilities

Modern GMP Manufacturing Suites, Pilot Plant, and Supporting Infrastructure

State-of-the-Art Facilities

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 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 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:

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.

▸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, 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.

▸Quality Control Labs for In-Process and Release Testing

▸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

We Operate Three Sites in New Jersey

Princeton Corporate Plaza
South Brunswick, NJ

Two GMP Manufacturing Suites, Pilot Plant, AMD, PD and QC Labs, Plus Supporting Infrastructure

Life Science & Engineering Center
Newark, NJ

Two GMP Manufacturing Suites, QC Labs, Cryopreservation Rooms, and More

Training & Corporate Offices
Newark, NJ

Corporate Offices, Storage and Warehousing, Training Labs, McKinsey Innovation & Learning Center

Princeton Corporate Plaza
South Brunswick, NJ

Two GMP Manufacturing Suites, Pilot Plant, AMD, PD and QC Labs, Plus Supporting Infrastructure

Life Science & Engineering Center
Newark, NJ

Two GMP Manufacturing Suites, QC Labs, Cryopreservation Rooms, and More

Training & Corporate Offices
Newark, NJ

Corporate Offices, Storage and Warehousing, Training Labs, McKinsey Digital Capability Center

CONTACT US

The BioCentriq Team

Our engineering team has years of experience designing, building, and managing facilities that meet the unique requirements that come with cell therapy manufacturing. The team has a full understanding of the compliance and regulatory guidelines as well as the space and environmental controls needed.

BioCentriq has implemented BMS (building management systems) and an EMR (environment monitoring reporting) system, both of which provide the support and data we need to maintain continuous control and compliance of our environment.

Learn more about our people.

OUR PEOPLE

“I enjoy the challenges of designing and operating cGMP facilities for cell and gene therapies and bring years of experience from my time spent at Celgene/BMS and Novartis.”

Todd Wozniak, MBA, MSJ, M.Sc.

Senior Director of Engineering

"I use my 20+ years of experience in GMP facility maintenance reliability programs to ensure that our client’s therapies are being developed and manufactured in an environment that is consistently up to standards, well-organized, process-driven, and top-of-the-line."

Neeyav Shah

Validation Manager

Learn More About Our New GMP Clean Suites

Designed to accommodate a variety of cell therapy manufacturing projects, our two additional clean rooms and supporting infrastructure are a strategic and much desired addition to the current pilot plant operations at the Princeton Corporate Plaza.

BioCentriq is already utilizing clean rooms for clinical manufacturing at our Newark, NJ site. Our new GMP facility—now open in South Brunswick, NJ—will provide additional capacity to support market demand.

LEARN MORE

FAQ About BioCentriq's Facilities

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