bluebird bio, Clinical Manufacturing Facility

DPS was retained as the design partner to perform the Concept Design for a cGMP clinical manufacturing facility/Pilot Plant for a CAR-T cell therapy product.

Location: Massachusetts
Sector: Cell Therapy

About This Project

This project focused on developing a pilot plant-scale facility to accommodate the production requirements.

Project Scope

The pilot plant contains two (2) ISO7 suite stations, associated incoming and outgoing ISO8 material/personnel airlocks, and an adjacent ISO8 media/material preparation rooms. Furthermore, within the scope is inclusion of a Process Development lab as well as a Quality Control testing space.

DPS developed options to meet bluebird bio’s process requirement and included the evaluation of the  appropriateness of each option for the required cell therapy products and processes. The project goal was to develop a concept design for a new facility, including project cost estimate and execution schedule.

The clinical manufacturing pilot suites included a 10,000 SF fit-out with segregated cGMP cleanrooms within two (2) suites, together with supporting lab space.

Back to top