cGMP Production Facility for Manufacture of Clinical Biopharmaceuticals
The FDA licensed cGMP manufacturing facility in Princeton has been used for the manufacture of clinical-stage biopharmaceutical products and for the manufacture of a commercial monoclonal antibody product for more than 17 years. This suite covers an area of approximately 25,000 ft2 and consists of dedicated media and buffer formulation areas, three cell culture suites, a downstream purification suite and necessary support functions.
Single-Use Bioreactor Suite
The single-use manufacturing suite is used for the production of early stage clinical products, Phase I/II and III (pre-process validation). The suite features 250L and 1,000L HyClone single-use bioreactors (SUB) for drug substance production and is supported by media and buffer formulation and necessary support functions.
2500 L Stainless Steel Bioreactor Suites
Two stainless steel manufacturing suites are also designed for the production of early-stage clinical material, Phase I/II and III (pre-process validation). The suites feature 300 L and 2500 L stainless steel bioreactors for Drug Substance production and are supported by media and buffer formulation along with necessary support functions.
Downstream Processing
The downstream purification suite consists of three downstream processing rooms with multiple chromatography skids. Two of these rooms are used for pre-vial processing and the third room is dedicated to downstream processing after viral removal (by nano-filtration) has been achieved (post viral.) Columns up to 80 cm in diameter have been run in the facility to yield multi-kg batches of drug substance.
Equipment
- 50 L, 250 L and 1000 L HyClone single-use bioreactors
- 300 L and 2500 L stainless steel bioreactors
- UF/DF skids
- Multiple unit operation downstream processing skids
- Virus removal by nano-filtration
- Bulk filling into PETG bottles or bags