Grand River Aseptic Manufacturing Receives
Zero Observations from FDA Inspection, Aiding in the Supply of Bavarian
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
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.