Boehringer Ingelheim has broken ground on a $217m expansion of its Fremont facility in California, US.
The facility manufactures monoclonal antibody therapies and other proteins based on mammalian cell culture technology in the areas of immunology, rheumatology, and oncology.
The expansion is expected to increase the facility’s manufacturing capacity by one-third upon completion by 2018. It will generate 300 new high-wage and highly-skilled jobs in the region.
The Fermont facility is located in the San Francisco Bay area, which is one of the world’s biggest biotechnology clusters.
Boehringer Ingelheim invests 20% of its net sales into research and development (R&D). Its latest investment in the Fremont facility will further strengthen the Bay area’s research activities and enable patients to access high-quality medicines.
The expansion project will add a 12,000l bioreactor and a 3,000l media feed tank to the Fremont facility. State-of-the-art equipment and gene expression biotechnology will be used to produce both biologics and biosimilars at the plant.
The products produced at the facility will be used for manufacturing other pharmaceutical products by various biopharmaceutical manufacturers.
Production of biologics and biosimilars will begin by growing cells for a specified period of time. The cells are then fermented in a large container and specific media is added to enable the cells to grow and secrete the desired protein or antibody.
The cells are purified using filters and resins, which remove various impurities including viruses, cell debris, and other undesirable elements. The purification process provides a product suitable for human use.
The State Treasurer’s Office has provided two tax credits worth $25.5m in total for the project.
The Fremont facility was acquired by Boehringer Ingelheim from Amgen in January 2011. Originally spanning 100,000ft², the facility has eventually been expanded to 300,000ft².
The design of the facility features extensive use of glass, which provides visibility into production suites and symbolises open and transparent collaboration between the customer and the company.
The facility can produce multiple products simultaneously as each production line is a separate operation having its own purification facilities. It also includes development labs, QC labs and a good manufacturing practice (GMP) compliant pilot plant.
The plant is equipped with development-stage stainless steel bioreactors in 2l and 5l capacities and pilot-scale stainless steel bioreactors in 30l and 100l capacities. Single-use bioreactors in non-GMP and GMP scales are also available in 100l, 500l, and 1,000l capacities.
GMP-scale stainless steel bioreactors are available in 2,000l and 15,000l capacities. In addition, the facility is equipped with cell banking, cell culture, harvest, and purification facilities, column and membrane chromatography technologies and filtration technologies.
Boehringer Ingelheim’s Fremont facility provides services such as evaluation and optimisation of cell culture processes and can also develop disposable cell cultures. Comparability and stability studies and GMP cell banking can also be carried out at the facility.
The plant is equipped with small-scale to commercial-scale production capabilities. Products in the clinical-stage or hundreds of kilograms a year of approved products can be produced at the plant.
The facility also has fill/finish, packaging and medical device assembly capabilities.
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