Grand River Aseptic Manufacturing (GRAM), an injectable contract development and manufacturing organization (CDMO), has entered into an agreement with Janssen Pharmaceuticals, Inc., one of the Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine candidate.
The agreement includes the technical transfer and fill and finish manufacture of Johnson & Johnson's SARS-CoV-2 vaccine candidate. Teams from both companies are working to transfer the manufacturing process to GRAM's new, state-of-the-art facility, and are swiftly preparing for the start of vaccine production.
GRAM is expanding domestic fill/finish capacity for COVID-19 vaccines and therapeutics for companies that have agreements with the federal government to meet its Operation Warp Speed goals. The GRAM expansion is funded, in part, by the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services, in collaboration with the Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
J&J’s vaccine candidate being manufactured at GRAM is being developed, in part, with funding from BARDA which is expected to result in 100 million doses of the investigational vaccine which the federal government will own.
GRAM is performing advanced aseptic fill and finish services to help ensure that supply of the vaccine candidate would be available upon regulatory approval. GRAM will utilize its 60,000 sq.-ft. large-scale fill and finish facility located in Grand Rapids, MI.
"Should their vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the COVID-19 pandemic alongside Johnson & Johnson is an extraordinary privilege," said Tom Ross, President and CEO of GRAM. "Our team is enthusiastic, dedicated and focused on supporting Johnson & Johnson in the fight against COVID-19."