Sanofi (Genzyme) 31NYA Pilot Plant, MA
Genzyme biologics R&D is developing an integrated continuous bioprocessing platform for recombinant therapeutic proteins.
About this project
Genzyme Biologics R&D is developing an integrated continuous bioprocessing platform for recombinant therapeutic proteins. To further mature this new manufacturing platform Genzyme wish to conduct full scale development studies (up to product capture step) in a proposed Biologics R&D development facility. DPS was awarded full A/E design from concept through detail design for the redevelopment of 31 NYA to meet this requirement.
The new process development facility encompasses retrofitting an area of ~ 20,000 square feet and will consist of two operational spaces, a production area and a media area, plus support space. The facility will comprise single use technology (SUT) and include wave bags and stirred SUBs up to 500L sizes. The media and buffer make up area is in fixed stainless vessels to 2000L with media and buffer hold in single use bags up to 2000L. The project includes clean utilities and cold rooms.
A notable attribute of this project is the establishment of a continuous processing platform.
The project scope involves the redevelopment of an existing facility to a bioprocess pilot facility which will meet the following objectives:
- Evaluate and confirm selection of disposable bioreactor, cell retention technology, and Periodic Counter-Current chromatography (PCC) design
- Assess and improve equipment and process manufacturability
- Demonstrate “closed system” operation which is critical to support design of Quantum Leap facility
- Demonstrate full scale Proof of Concept (PoC) [up to product capture]
- Perform ‘at scale’ studies to support process development of current and future products
- Gain full scale operational experience and expertise early on to ensure project success when introducing new products.
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