Boehringer Ingelheim's 300,000 square-foot multi-product manufacturing facility in Fremont, USA is dedicated to the manufacture of monoclonal antibody therapies and other proteins from mammalian cell culture technology. It includes process development labs, a pilot plant, and large-scale bioreactors for manufacturing biologics for clinical studies as well as for commercialization.
The biologics manufacturing facility features flexible scales of up to 15,000 L bioreactors and is certified with both the US Food and Drug Administration (FDA) and in accord with international biologics manufacturing regulations. It also has parallel mammalian cell culture and recovery suites with complete inoculum, cell culture, purification and Fill & Finish capabilities. Each production line is an integral, stand-alone operation with its own purification facilities. As a result, the facility can accommodate multiple products simultaneously at clinical scale, or it can produce up to hundreds of kilograms per year at the 15,000 L scale.
The Fremont facility has state-of-the-art process development labs. The pilot plant is fully synchronized with GMP operations.
Boehringer Ingelheim Fremont operates two identical, independent trains for cell culture and purification facilities of up to 15,000 L. Each is equipped with complete cell banking, cell culture, harvest, and purification capabilities. These flexible, parallel trains can be operated independently to produce two different antibody products simultaneously.