Merck Biologics Pilot Plant - Design-Build

The 260,000-square-foot standalone facility, designed and built by Fluor, provides Merck with state-of-the-art bioprocess research and development capabilities.

The architecturally striking facility is a four-story, steel-frame structure with three stories for pilot plant suites and a fourth story for R&D laboratories and offices.

Client's Challenge

The facility plays an integral role in the development of biologically made products in the Merck pipeline.

It supplies clinical materials for human studies; develops economical, scalable processes and transfers them to Merck's manufacturing division; develops analytical assays for product release and characterization; and develops regulatory packages required for product licensure.

Fluor's Solution

Fluor team members were located in Merck's office in Somerset, New Jersey for the first two phases: planning session and basis of design.

The project location then moved to Fluor's Greenville, South Carolina office for the ensuing design development and construction documents phase.

During the course of the project design, appropriate CGMP, HAZOPS, and constructability reviews were conducted in conjunction with formal P&ID reviews.

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

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Conclusion

The Merck facility follows FDA CGMP requirements to provide large-scale pilot plant capability for the production of clinical trial materials.

The facility includes clinical manufacturing through filling, finishing, and shipping for Phase I, II, and efficacy clinical trials for both the United States and the European Community.