Projects

Science and Technology Case Studies

Bristol-Myers Squibb
Clinical Supplies Manufacturing Facility—Building 115
New Brunswick, New Jersey

Torcon was construction manager for a two-phase renovation and fit-up for Bristol-Myers Squibb that created a state-of-the-art clinical manufacturing center at the company’s New Brunswick campus. The finished facility is a full-service clinical manufacturing area with the capability to scale-up and deliver a variety of oral solid and liquid dosage forms, including sterile products, regardless of product potency or the use of solvents in the manufacturing process. Building 115 is the first GMP operational clinical sterile continuous process isolation facility in the United States.

The project involved the adaptive reuse of an existing 100,000 square foot shell building, which allowed the project to proceed with minimal disruption to the site and maximized the utilization of site infrastructure already in place. In its initial phase, Torcon fit-out a 93,000 square foot space for clinical supplies operations (CSO), which provides full containment for expanded Oral Solid Dose operations and the most flexible clinical-scale continuous barrier line in the United States for sterile products. The facility was designed for the manufacturing of OSD batches up to 400Kg and parenteral liquid fill batches up to 250L. The new facilities provide BMS with the capacity and capabilities to deliver supplies for increasing clinical demands according to current good manufacturing practices (cGMP.) The CSO facility is designed to handle aqueous, solvent and cytotoxic based processes.

The second phase of renovation added long-term stability (LTS) batch operations to the CSO in support of BMS’ oral solid dosage manufacturing of potent compounds. The space generally encompasses three process rooms with support areas: bin blender, aqueous coating and spray drying. Each room includes a floor scale and marble tables for portable balances, and is integrated with the site Delta V control system.

A stand-alone product technology center (PTC) was also added in the second phase of the project to conduct both process development and scale up, with batch sizes of 20Kg to 100Kg. The PTC facility supports OSD unit operations for potent compounds having exposure control band 4. The ten process rooms house fixed equipment including a pan coater for aqueous film coating for tablets, a 50 liter one pot high shear processor, a bin blender and a downflow booth or isolator for weighing.

Isolation technology was employed in this project, offering an improved compliance profile and a high level of protection for the product and personnel. Due to the solvent and cytotoxic requirements, the process equipment is encapsulated with barrier isolation technology to ensure the use of single pass air.

Specialized equipment installed to support oral solid dosage and parenteral production includes a high shear granulator, bins and blenders and table press. Dedicated pot processors have been installed for the oral solid dosage operations, while parenterals operations received lyophilizers, lyophilizer loaders, vial filling lines, formulation vessels and vial washers. The completed facility has a new chiller plant, as well as all new process utilities, a new WFI and clean steam generator, clean-in-place systems and a water neutralization and deactivation system.