25 September 2020 - - Michigan, US-based injectable contract development and manufacturing organisation Grand River Aseptic Manufacturing has entered into an agreement with US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Pharmaceuticals, Inc business to support the manufacture of its SARS-CoV-2 vaccine candidate, the company said.

The agreement includes the technical transfer and fill and finish manufacture of Johnson and Johnson's SARS-CoV-2 vaccine candidate.

Together, teams from both companies are working diligently 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) 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).

The Johnson and Johnson vaccine candidate being manufactured at GRAM 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 m doses of the investigational vaccine which the federal government will own.

GRAM is well-equipped to support the manufacturing of Johnson and Johnson's COVID-19 vaccine candidate.

By performing advanced aseptic fill and finish services, GRAM is helping to ensure that supply of Johnson and Johnson's COVID-19 vaccine candidate would be available upon regulatory approval. GRAM will utilize its world-class 60,000 sq. ft. large-scale fill and finish facility located in Grand Rapids, MI.

Grand River Aseptic Manufacturing, Inc, a modern parenteral contract development and manufacturing organization, delivers customised 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 modern facilities support pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.