Facility of the Year Award Winner in Equipment Innovation
This innovative facility brought early and late phase clinical manufacturing and development scale-up
together within a single facility to create a Pharmaceutical Development Center of excellence on the
Bristol-Myers Squibb (BMS) New Brunswick, New Jersey, USA campus.
A phased approach was initiated to adapt an existing building to allow full implementation of lessons learned
as containment and process automation technology was integrated into existing operation. Phase one
implemented a state-of-the-art Clinical Supply Operations expansion facility-including full containment for
expanded Oral Solid Dose (OSD) operations and the most flexible clinical-scale continuous barrier line in the
United States for Sterile products, according to a spokesperson for BMS.This highly technical facility was
designed for manufacturing OSD batches up to 400Kg and parenteral liquid fill batches up to 250L. The goal
was to create a flexible facility capable of performing multi-product clinical scale manufacturing and
processing solvent-based and potent compound operations. The first phase consisted of approximately 93,110
sq. ft. including processing, manufacturing, support, and mechanical space.
Phase Two built upon the technologies in Phase One and added additional processing space and scale to the
Oral Solid Dose clinical operation and a new stand-alone Product Technology Center for development scale-up
activities. The addition to Oral Solid Dose Operations allows the manufacture of Long Term Stability batches
within the Clinical Supply Operations facility in at least one-tenth commercial scale.
The new facilities provide BMS with the increased capacity to meet clinical demand and deliver Compliance,
Productivity and Technical Innovation to meet present and future drug development pipeline needs - ultimately
helping speed products to market.
Engineering Design Firm: IPS, Inc., Lafayette Hill, Pennsylvania, USA
Construction Manager: Torcon, Inc., Red Bank, New Jersey, USA