Novartis CMF and PDU Facility Upgrades
Emeryville, California

Major modifications to Novartis’s manufacturing facilities must be constructed and validated within their annual shutdown period. Completing complex projects within a limited time frame requires close coordination throughout the design effort, pre-ordering of major components and equipment and early installation of systems not located within the GMP controlled areas. VDK was part of a design/build team selected by Novartis to implement a series of compliance upgrades for the Clinical Manufacturing Facility (CMF) and the Process Development Unit (PDU) at the Novartis Emeryville Campus.

The work in the CMF included construction of a new multi-product formulations laboratory and renovation of the locker/gowning/toilet room core to provide flexibility for production processes and enhanced cGMP compliance.

The PDU improvements included construction of a new inoculum preparation laboratory to serve the production unit and the installation of new pass-through equipment to improve the flow of glassware between the fermentation suite and the glass washroom.