Johnson & Johnson (J&J) company Janssen Pharmaceuticals has partnered with injectable contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (GRAM) to produce its SARS-CoV-2 vaccine candidate.
The scope of the deal comprises technical transfer, and fill and finish manufacture of J&J’s SARS-CoV-2 vaccine candidate.
GRAM stated that it is having modern equipment to manufacture J&J’s Covid-19 vaccine candidate.
Upon receiving regulatory approval, GRAM will manufacture the vaccine candidate at its 60,000ft² large-scale fill and finish facility in Grand Rapids of Michigan.
The teams from both firms are focused on the transferring of the manufacturing process to GRAM’s new facility, as well as preparing to begin the vaccine production.
GRAM is increasing its fill/finish capacity for Covid-19 vaccines and therapeutics for companies that have agreements with the federal government to achieve its Operation Warp Speed goals.
GRAM also secured funds for its expansion activities from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
BARDA is also partly funding J&J to support the development of the Covid-19 vaccine candidate, which is being manufactured by GRAM.
BARDA, along with JPEO-CBRND, is providing funds for a demonstration of manufacturing capability, which is expected to produce 100 million doses of the investigational vaccine. It will be owned by the federal government.
GRAM president and CEO Tom Ross said: “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.
“Our team is enthusiastic, dedicated and focused on supporting Johnson & Johnson in the fight against Covid-19.”
Recently, J&J has started a phase 3 trial for the JNJ-78436735 (Ad26.COV2.S) vaccine candidate developed by Janssen Pharmaceutical Companies against the prevention of Covid-19.