CDMO to conduct fill and finish manufacture of COVID-19 vaccine
US outsourcing organisation GRAM is set to undertake the aseptic fill and finish manufacture of J&J’s COVID-19 vaccine candidate.
Johnson & Johnson (J&J) has entered into an agreement with a contract development and manufacturing organization (CDMO) to support the manufacture of its vaccine candidate, called Ad.26.COV2.S, to combat SARS-CoV-2, the virus causing the COVID-19 pandemic.
Grand River Aseptic Manufacturing (GRAM), an injectable CDMO, will work with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of J&J, on the aseptic fill and finish manufacture of the vaccine. The teams from both companies are now working to swiftly prepare for the start of vaccine production.
“Should their vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the COVID-19 pandemic alongside J&J is an extraordinary privilege,” said Tom Ross, President and Chief Executive Officer (CEO) of GRAM. “Our team is enthusiastic, dedicated and focused on supporting J&J in the fight against COVID-19.”
If the vaccine is approved, GRAM has announced that the vaccine will be readily available for supply. The CDMO will use its large-scale fill and finish facility located in Grand Rapids, Michigan, US.
The outsourcing facility is expanding domestic fill and 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 US 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 Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
BARDA, in collaboration with JPEO-CBRND, is funding a demonstration of manufacturing capability that is expected to result in 100 million doses of the investigational vaccine which the federal government will own.