Emergent BioSolutions, a global life sciences company offering specialty products and contract development and manufacturing services, announced a $75 million investment in its Canton, MA facility focused on contract development and manufacturing (CDMO) of drug substances for live viral vaccines, including the company’s smallpox vaccine. In parallel, the firm announced a collaboration with Mount Sinai Health System and ImmunoTek Bio Centers to develop Emergent’s Hyperimmune Globulin (COVID-HIG) product candidate with $34.6 million of U.S. Department of Defense funding.
First, the company would leverage its biologics expertise to meet today’s future needs, reported the executive vice president of manufacturing and technical operations, Sean Kirk. Ultimately, this state-of-the-art, multi-suite operation up to 1000K scale, fulfills future molecule-to-market CDMO services for viral vector and gene therapy innovators. With drug development services out of its Gaithersburg, MD location, drug substance manufacturing of Canton, and drug product manufacturing at its Rockville location (also under expansion), the company seeks to meet the demands of healthy and growing precision treatments.
Mount Sinai Deal
Mount Sinai and Emergent will conduct clinical trials to evaluate COVID-HIG for post-exposure prophylaxis of COVID-19 in front-line healthcare workers and support a potential Expanded Access Program for military personnel with funding from the U.S. DOD. In parallel, ImmunoTek will extend an operating license and provide training to Mount Sinai to establish onsite plasma collection to support the production of COVID-HIG.
What is COVID-HIG?
This is a COVID-19 Hyperimmune Globulin-based product. Hyperimmune globulin, sometimes referred to as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people who were previously infected and recovered from an illness; in this case, COVID-19 caused by the virus SARS-CoV-2. In order to produce plasma-derived therapeutics that can be administered to patients in need, plasma must be collected from a pool of human donors and then manufactured or fractioned into specialized therapeutic products. Hyperimmune globulin treatments have been used successfully to treat other viruses.
Mount Sinai Position
“There is emerging evidence that convalescent plasma is an effective treatment for COVID-19 patients,” said David L. Reich, M.D., President and Chief Operating Officer of The Mount Sinai Hospital. “Therefore, hyperimmune globulin may become an effective option in the prevention and treatment of COVID-19 currently, in the absence of a vaccine, as well as in the future, particularly for patients who do not develop immunity from a vaccine. It is imperative that we have more options to prevent this terrible disease in front-line workers and other high-risk populations and to potentially decrease the severity of illness in those infected. We are eager to collaborate with Emergent and ImmunoTek to advance the science and identify effective therapeutics in the fight against COVID-19.”
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