There is an urgent and pressing need to identify non-animal cell derived production hosts in biomanufacturing for manufacture of recombinant antibodies. Microbial hosts offer the distinct advantages of lower cost inputs, reduced operating costs, and higher volumetric productivity. Due to these processing advantages, the use of microbial hosts is expected to improve accessibility and sustainability of antibodies by reducing process cost and complexity. Led by Dr. Kurt Selle with BTEC, this project proposes to use the filamentous fungus C1 as a novel microbial host for monoclonal antibody production. The expected outcomes of this work will be to derisk the deployment of C1 as a microbial host for monoclonal antibody manufacture and to generate preliminary data for additional grant funding from the Gates Foundation.
The resulting work on characterizing the scale up and product quality of C1 expressing Nivolumab supports a promising alternative to animal cell-based processes to produce monoclonal antibodies. The project will also enable BTEC to produce larger quantities of Nivolumab (i.e., increase productivity), which will enhance the ability to support downstream research efforts for C1 expressed proteins. BTEC will provide in kind contributions to the project in the form of equipment usage time.
The grant is leveraged by the Gates Foundation grant of approximately $750,000 from July 1, 2025, to December 31, 2026: Low Cost All Membrane Processes to Purify MAM01 Antibodies from C1 Cell Lines. The current phase of funding from the Gates Foundation will be used to explore continuous downstream processing of C1 fermentation supernatant containing anti-malarial antibody. The expectations for a renewal of the Gates foundation proposal will require demonstration of up- and downstream processing of C1 produced Nivolumab and the work will directly support de-risking the process and generating preliminary data to support a follow-on proposal to phase 2 funding from the Gates Foundation.