Biogen Inc. (Cambridge, MA, USA) will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir Biotechnology, Inc.’s (San Francisco, CA, USA) SARS-CoV-2 monoclonal antibodies.
Both the companies have finalized a process development and manufacturing agreement based on the letter of intent that they had announced in March. The execution of this definitive agreement allows Vir to advance the development of its antibody candidates and complements its existing manufacturing agreements with WuXi Biologics and Samsung Biologics Co., Ltd.
Under the terms of the agreement, Biogen and Vir will collaborate to develop highly productive clonal cell lines and clinical and commercial manufacturing processes for Vir’s SARS-CoV-2 antibody candidates. These processes are designed to be transferrable to global biomanufacturing facilities designed for advanced biologics production. As part of the agreement, Vir has contracted with Biogen to conduct cGMP clinical manufacturing in the US and provide technical support to facilitate rapid process transfer to Samsung Biologics, and potentially other large-scale biomanufacturing facilities in the US and all other regions of the globe in order to provide reliable supply of a potential commercial product.
“Biogen’s world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced,” said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. “The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity.”