Therion Biologics Corporation cGMP Production Facility and Fill-Finish Suite
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Overview
Therion Biologics Corporation required an FDA-validated Current Good Manufacturing Practice (cGMP) manufacturing space to produce two of their vaccines for the treatment of pancreatic and prostate cancer for Phase II clinical trials. Linbeck served as the Construction Manager to undertake this challenging project using a fast-track construction delivery of 4 months. Utilizing leased warehouse space, Linbeck gutted roughly 6,000 SF to build two Class 10,000 clean rooms. The project also included two new cell culture fermentation suites using roller bottle technology, new foundations for heavy process equipment, a USP purified water system, a custom-built HEPA-filtered air handling system, warm rooms, incubators, and centrifuges. Linbeck also constructed a Fill-Finish Suite in support of Therion’s production of vaccines for Phase III clinical trials.
