HHS and Dept. of Defense call upon the U.S.-based CDMO to expand domestic fill/finish capacity under Operation Warp Speed
Grand Rapids, MI – August 6, 2020 – Grand River Aseptic Manufacturing (“GRAM”), a leading parenteral contract development and manufacturing organization (CDMO), has been selected by the U.S. Department of Health and Human Services and the U.S. Department of Defense to support the expansion of the United States’ capacity for manufacturing and distributing vaccines or therapeutics related to the COVID-19 pandemic.
As a U.S.-based CDMO, GRAM is well-equipped to support the pharmaceutical supply chain’s critical needs by offering state-of-the-art technology and delivering high quality products. By providing the capacity to perform advanced aseptic fill and finish services – the last two steps in the manufacturing process for vaccines or other therapeutics – GRAM is helping to ensure that the country will have sufficient domestic supply to make life-saving biopharmaceutical products available to Americans as quickly as possible.
“We are extremely honored to be chosen to serve our country and help respond to the demands and challenges presented by the COVID-19 pandemic,” said Tom Ross, President and CEO of GRAM. “As a homegrown company with a strong culture built on teamwork and accountability, our team will confidently deliver the safest and highest-quality solutions that will ultimately be life-saving for the American people.”
Through this public-private partnership, the federal government is reserving fill/finish capacity on a commercial filling line for use by federal partners that are developing COVID-19 vaccines or therapeutic treatments. GRAM’s capacity not only supports the U.S. government’s Operation Warp Speed efforts and the COVID-19 pandemic response, but also increases U.S. preparedness for future public health emergencies.
The contract was awarded as a collaboration between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), and the Army Contracting Command.
GRAM will utilize its new, cutting-edge 60,000 sq. ft. large-scale fill/finish facility located in Grand Rapids, MI. to support the effort. In total, the CDMO has three manufacturing facilities and more than 100,000 sq. ft. of production space. GRAM’s large-scale fill/finish facility was designed for growth and contains additional space to add more equipment and fill suites as demand continues.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. (“GRAM”), a modern parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s expert project managers and modern facilities support pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
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140 Front Avenue SW
Grand Rapids, MI 49504