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Projects

Commissioning and Qualification of Biologics Manufacturing

Shire, Lexington, MA

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
Client Name: Shire
Region: AmericasCountry: United StatesOffice: Somerset, NJ
Services: Commissioning, Qualification & Validation, Project ControlsIndustries: Pharmaceutical, Biotechnology & BiomanufacturingFacility Type: Manufacturing
Size: 200,000sfAwards: 2011 FOYA Honorable Mention
Client Name: Shire
Region: AmericasCountry: United StatesOffice: Somerset, NJ
Services: Commissioning, Qualification & Validation, Project ControlsIndustries: Pharmaceutical, Biotechnology & BiomanufacturingFacility Type: Manufacturing
Size: 200,000sfAwards: 2011 FOYA Honorable Mention

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