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Sterile Fill/Finish Facility Upgrade

Confidential, East Coast, United States

The sterile formulation and fill operation has committed to making improvements to their facilities and equipment to ensure continued GMP compliance. These commitments have been made to several regulatory agencies, including FDA, EMA, MHRA, TGA, and WHO. 

As the project concept developed and options were considered, supply requirements became a factor to provide back-up supply for another facility as well as potential additional supply for emerging markets.

The project drivers were two-fold; compliance and supply. More specifically, the following:

  • Meet compliance commitments and internal compliance requirements
  • Supply of up to 20MM LVV doses to network
  • Network LVV final formulation & filling capacity of 65 MM doses
  • Successful ongoing management of both design and construction activities in multiple areas of the facility
  • Integrated multiple CGMP reviews during the design-build process
  • Provided EPCM services for eight areas of scope over a period of three years and ongoing
  • Unique HVAC and BAS philosophies and concepts developed

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