This project brought early and late phase CGMP clinical manufacturing and development scale-up areas together within a single facility allowing Bristol-Myers Squibb to develop and deliver increased compliance, productivity, and technical innovation to meet present and future drug development pipeline.
The finished facility was a full-service clinical manufacturing area with the capability to scale-up, deliver and fill 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.
IPS process architects programmed the facility for current and future functional needs and space requirements while balancing against competing budgetary objectives.
- Innovative integration of overall manufacturing strategy with scalable design for sterile and oral solid dosage products
- Incorporates innovative technologies into existing facility for solvent-based and potent compounds to promote safety, quality and compliance
- Wireless technology and electronic batch records allow development data to be automatically gathered during GMP manufacture
- Increased GMP development capabilities allow QbD and PAT throughout the clinical program
- CGMP flammable liquid handling of solvents
- Increased overall capacity and productivity for the pipeline
- Simultaneous multi-product processing
- Facilitates technology transfer to commercial sites
- Cutting edge, wireless Delta V data gathering
Region: AmericasCountry: United StatesOffice: Somerset, NJ
Services: Architecture, Site Analysis & Master Planning, EngineeringIndustry: PharmaceuticalFacility Type: Manufacturing
Size: 132,400sfAwards: 2008 ISPE Facility of the Year Award