Grand River Aseptic Manufacturing (GRAM), a parenteral drug product contract development and manufacturing organization (CDMO), has entered into an agreement with Bavarian Nordic, a Denmark-based vaccine company, to fill and finish JYNNEOS smallpox/monkeypox vaccine. The agreement was supported by the Department of Health and Human Services (HHS) and the Biomedical Advance Research and Development Authority (BARDA) to increase domestic vaccine supply.
 
“We are happy to play our part and are proud to be in a position to support Bavarian Nordic and the U.S. Government with the monkeypox outbreak response,” said Tom Ross, President and CEO of GRAM. “GRAM is putting forth all efforts possible to accelerate the manufacturing of the vaccine.”
 
GRAM recently announced the completion of the installation of two new fill lines at its world-class filling facility. GRAM now has three fill lines available and triple the capacity ready to serve the needs of new and existing customers. With the timely completion of the expansion, GRAM is ideally positioned to support the manufacture of JYNNEOS and will dedicate one fill line and associated manufacturing staff to produce as much of the critical vaccine as needed to support the public health emergency. Production of other client products that GRAM supports will continue as planned and will not be impacted by vaccine production.
 
“GRAM is proud of its substantial experience in supporting public health emergencies. We were on the front line working with the U.S. Government to accelerate the manufacture of COVID-19 vaccines. Our expert team members have the experience and knowledge from supporting Operation Warp Speed, and we are confident in accelerating the technical transfer of the monkeypox vaccine and ramping up production, just as we did in 2020. Importantly, with our recent expansion, GRAM can continue to focus on our core business of supporting clinical and commercial biotherapeutics while managing the vaccine production,” said Ross.