Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection, Aiding in the Supply of Bavarian Nordic’s JYNNEOS®
FOR IMMEDIATE RELEASE
GRAND RAPIDS, Mich. (March 17, 2023) – Grand River Aseptic Manufacturing (“GRAM”), a leading sterile injectable pharmaceutical contract manufacturer of biologics, small molecules, and vaccines, announces the approval of Bavarian Nordic’s recent Biologics License Application (BLA) supplement authorizing the manufacture of JYNNEOS®. In conjunction with that approval, GRAM recently hosted a regulatory inspection by the Center for Biologics Evaluation and Research (CBER) that resulted in zero observations and Federal Drug Administration (FDA) approval of the company’s expanded filling facility and new finishing center.
GRAM’s partnership with Bavarian Nordic and the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS) achieved remarkable timelines by completing the tech transfer in only four months. This approval marks the second time in the past two years that GRAM’s facilities were authorized to manufacture a vaccine to support a declared Public Health Emergency (PHE).
“The collaborative relationship between Bavarian Nordic, BARDA, and GRAM demonstrates the breadth of expertise and trust in one another that results in success,” said Tom Ross, President and CEO of GRAM. “I am privileged to lead a CDMO with an outstanding quality record and a team whose technical expertise and authenticity shine through in every project.”
As previously announced, GRAM broke ground on another facility expansion in September 2021. Twelve months later, the filling facility expansion was completed with the installation and qualification of a new VarioSys® modular syringe and vial filler and a second Bausch+Ströbel vial filler with SKAN isolator technology. The substantial capacity expansion was a notable achievement to serve GRAM’s current and future customers. At the same time, GRAM achieved a swift tech transfer of JYNNEOS®, working closely with HHS, BARDA, and Bavarian Nordic. Ross noted, “the ability to respond quickly while handling multiple important projects distinguishes GRAM in the CDMO marketplace.”
This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services under agreement number 75A50122C00042.
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 support pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
Media Contact
Chelsea Keeton
Grand River Aseptic Manufacturing
ckeeton@grandriverasepticmfg.com
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