Encon provided Alexion Pharmaceuticals with a full range of engineering services in their search for and renovation of an appropriate building for their large‐scale biotechnology manufacturing processes. Services provided included site selection, process development, test‐fit, conceptual development, engineering design, procurement, and construction management.
The facility was designed to FDA and EU regulatory requirements. The design included a cGMP mammalian cell culture production train with two 10,000L bioreactors and harvest tank. Support functions included media prep, buffer prep, and buffer hold. Downstream processing functions‐‐pre‐ and post‐viral purification suites and bulk filling‐‐were also provided. A pilot plant for development of biotechnology products that was integral to the main manufacturing area was also included in the project.
All process and building utilities were upgraded. New water pretreatment, WFI production, and distribution systems were installed, including a 9,000 lph vapor compression still, hot and ambient WFI distributions loops, and a pilot plant WFI system that was isolated from the production WFI system. A new clean steam generation and distribution system was also provided.
Process piping systems, providing the automated operation of five CIP systems and multiple product (media, buffer, and cell culture) transfer systems, were also included in the design. All production area HVAC systems were redesigned to be compliant with current FDA and EU requirements. New air handling units and ductwork systems were installed. The central plant chilled and condenser water systems were redesigned.