Extensive deployment of single-use technologies at commercial scale and implementation of fully single-use upstream process technology at 2,000L scale, with a peak plant capacity of 4x2000L. Facility includes clinical manufacturing capable of operating 500L perfusion bioreactors (all downstream purification processes).  Building features cell culture suites, purification suites, support services and a large administrative space.
Single-use technologies provided a number of benefits: reduced build time/time to market; decreased contamination risk; reduced cost of goods; increased flexibility; reduced environmental impact; decreased cycling time; decreased system complexity, reduced utility requirements and increased throughput.

• Speed to market was the primary driver of the project
• Project achieved goal to meet increased demand for Shire therapies
• Employed our fully integrated project methodology to leverage FATs, SATs and commissioning activities to support qualification efforts and reduce redundant and repetitive testing
• Our approach allowed for regulatory requirements to be completed earlier in the project to accommodate the very aggressive project schedule
• Utilized C&Q expertise and knowledge of biologics manufacturing to ensure FDA and EU guidelines, CGMP, GEP and Shire standards, guidelines and policies
• Technical leadership in improved efficiency, lower facility and operating costs and assured quality and controls