A fully integrated, purpose-built research, clinical, and manufacturing center.
Our cellular therapeutic candidates are designed and manufactured via a platform comprised of defined unit operations and technologies. The process is gradually developed from small to larger scales, incorporating compliant procedures to create GMP conditions. While based on a shared platform, each therapeutic candidate is unique, and for each new therapeutic candidate, a bespoke developmental phase individually customizes each engineering step to create a robust procedure. This procedure can later be implemented in a GMP environment to ensure the production of clinical batches. This work is performed in a research and development environment to evaluate and assess variability in each step of the process in order to define the most reliable production conditions.
150,000 sq.ft. Facility
We have an approximately 150,000-square-foot purpose-built facility located in Florham Park, NJ.
Our facility includes a cGMP-ready manufacturing center, along with dedicated research and office spaces and space for shared services.
Our facility includes nine GMP Grade C/ISO-7 and six GMP Grade D/ISO-8 manufacturing suites designed for the commercial production of cellular therapies and advanced biomaterials. We intend to manufacture all finished products in-house at our Florham Park facility. We have invested resources to optimize our manufacturing process, including developing improved analytical methods.