Merck New Biologics Pilot Plant

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This $200-million project comprises a 260,000 square-foot pilot plant with support laboratories and offices at Merck's existing campus at West Point, Pennsylvania. The standalone facility will be a four-story, steel-frame structure with three stories for the pilot plant and a fourth story for the labs and offices. The pilot plant will have two separate cell culture fermentation trains with two purification suites each. Support utilities will be self-contained. This building will include CIP, WFI, clean steam, and waste decontamination and neutralization. The facility will have its own media/buffer prep, fill/finish suite, filtering, and a glass/tank wash/sterilization area. All areas will be segregated and will have individual air handling systems, including Class 100, 10,000, and 100,000 clean rooms.

This facility will follow CGMP to provide large-scale pilot plant capability for the production of clinical trial material. The facility will include bulk manufacturing through filling, finishing, and shipping for Phase I, II, and efficiency clinical trials for both the United States and the European community.

The fill/finish suite will include lyophilization packaging, glasswash, CGMP storage, and warehousing with shipping and receiving. A bioanalytical lab is provided for development of analytical techniques and assays in support of the pilot plant.

The project was designed using 3D CAD to visualize the facility and eliminate interferences and rework during the construction phase.