Replimune, Clinical Manufacturing Facility
DPS was hired to provide engineering and design services for a new cGMP manufacturing facility having completed the process definition and test fit phases.
About this project
Our client, a new genetic medicines company involved in translating proprietary gene therapy technologies into novel treatments for patients, are currently at the pre-clinical development phase and are preparing to make a rapid transition into clinical development.
To support these aims, the DPS team was hired to design a new cGMP clinical manufacturing operations facility in a 106,000 SF shell building in Framingham, MA. The facility includes a self-contained, small-scale cGMP viral vector manufacturing operation embedded in an estimated build-out of 63,000 SF comprising a 21,000 SF manufacturing clean room and 42,000 SF of support space. The design includes all supporting utilities, infrastructure, and services, including QC labs, to support a Phase 1 / 2 manufacturing operation within a shell space that will also house office space.
The primary manufacturing areas consist of two manufacturing trains constructed in two phases. The scope of this project relates to Phase 1 only with fallow spaces left for future phases.
Phase 1 includes a cell culture room, virus inoculum room, virus production room, downstream purification room, a single buffer/media prep suite to serve both manufacturing trains, component preparation room, product filling, capping, inspection, labeling, and packaging area; and future space for automated filling, potential lyophilization, capping, inspection, labeling, and packaging.
The new facility layout has been developed to operate two manufacturing trains in parallel, but only one train will be outfitted with this project. The facility design will allow for future build-out of the second train with minimal impact to ongoing operations in the first train.
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