Grand River Aseptic Manufacturing to Fill and Finish Smallpox/Monkeypox Vaccines and Accelerate Domestic Supply
Grand River Aseptic Manufacturing (“GRAM”), a prominent 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.”
Two days ago, GRAM announced the completion of the installation of two new fill lines in their 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.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc., a prominent parenteral drug contract development and manufacturing organization with advanced technology, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules and vaccines, Grand River Aseptic Manufacturing’s elite equipment and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA, also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.
Contact
Chelsea Keeton
Grand River Aseptic Manufacturing
(616) 678-2400
ckeeton@grandriverasepticmfg.com