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A fully integrated, purpose-built research, clinical, and manufacturing center.
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Clinical Scale
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 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.
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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.
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GMP Suites
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.