Grand River Aseptic Manufacturing, J&J in Mfg Pact for COVID Vaccine
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has entered into an agreement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), to support the manufacture of J&J’s vaccine candidate for SARS-CoV-2, the virus that causes COVID-19.
The agreement includes the technical transfer and fill–finish manufacture of J&J’s vaccine candidate. Teams from both companies are working to transfer the manufacturing process to GRAM’s new $60-million 60,000-square-foot large-scale fill–finish facility in Grand Rapids and are 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 Operation Warp Speed, a US government initiative for accelerating the development of vaccines and treatments against COVID-19. The GRAM expansion is funded, in part by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, in collaboration with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
The J&J vaccine candidate is being developed, in part, with funding from BARDA. BARDA, in collaboration with JPEO-CBRND, also is funding a demonstration of manufacturing capability that is expected to result in 100 million doses of the investigational vaccine which the US federal government will own.
