Vertex, Gene / Cell Therapy Manufacturing Facility

DPS was engaged to assist Vertex in determining feasibility to build a multi-product, flexible Gene / Cell Therapy Manufacturing facility in Massachusetts.

Location: Massachusetts
Sector: Gene Therapy

About This Project

The Vertex Genetic Therapies Manufacturing Facility will include two cGMP Production Suites for the manufacture of two products. The two Production Suites will be separate, each will include its own locker room, and designed for containment of the respective products. Support utilities for the Production Suites will include purified water, water for injection (WFI), clean steam, compressed gases and waste handling.

Project Scope

As an initial step, Vertex was seeking support for the development of a Feasibility Study that formed the basis of subsequent design phases.  Both cGMP Production Suites will be designed for a maximum of Biological Safety Level 2 containment. The first suite will be used to execute upstream mammalian cell growth, transfection, downstream purification, and vial filling. Processes will make use of single use equipment and components.  The Production Suite will include support rooms for media and buffer preparation, component and equipment preparation and autoclaving, as well as cold room and freezer storage.

The other cGMP Production Suite will be used for cell culture, harvest, cryopreserved intermediate (CPI) aliquoting, along with drug substance / drug product (DS/ DP) formulation and filling. Processes will make use of single use equipment and components. The Production Suite will include support rooms for media preparation and the storage of released raw materials and consumables.

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