Grand River Aseptic Manufacturing was selected by the federal government to help support the process of developing and distributing a COVID-19 vaccine and/or treatment.
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids-based parenteral contract development and manufacturing organization (CDMO), said Thursday that it was selected by the U.S. Department of Health and Human Services and the U.S. Department of Defense to support the expansion of domestic capacity for manufacturing and distributing vaccines or therapeutics related to the COVID-19 pandemic through Operation Warp Speed.
GRAM will use its new 60,000-square-foot fill-and-finish facility that recently opened in Grand Rapids to support the effort. In total, the CDMO has three manufacturing facilities and more than 100,000 square feet of production space.
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 will help ensure the nation 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-and-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, according to the company.
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.
Grand River Aseptic Manufacturing
Founded in 2010, GRAM is a modern parenteral contract development and manufacturing organization that 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 project managers and facilities support pharmaceutical development and CGMP manufacturing, analytical testing and regulatory filing.