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The latest news, announcements and press releases from Grand River Aseptic Manufacturing (GRAM).
To meet heightened customer demand, GRAM has embarked on another expansion!
Less than one year after the completion of our large-scale filling facility GRAM’s new finishing and warehouse expansion is underway, bringing our total number of GMP manufacturing facilities to four.
Grand River Aseptic Manufacturing (“GRAM”), a leading injectable contract development and manufacturing organization (CDMO), has entered into an agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine candidate.
The agreement includes the technical transfer and fill and finish manufacture of Johnson & 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.
“Should their vaccine candidate be approved, the opportunity to serve the population with a vaccine to combat the COVID-19 pandemic alongside Johnson & Johnson is an extraordinary privilege,” said Tom Ross, President and CEO of GRAM. “Our team is enthusiastic, dedicated and focused on supporting Johnson & Johnson in the fight against COVID-19.”
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 U.S. 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).
“Onshore” manufacturing has become a bit of a buzzword term in the age of COVID-19 as lawmakers push for a stable drug supply chain on U.S. soil. But for small CDMO Grand River Aseptic Manufacturing (GRAM), that made-in-America ethos is stamped in its DNA, and a brand-new finish-fill plant could help it target even more U.S. drugmakers.
Michigan-based GRAM completed a $60 million expansion to install a “large-scale” fill-finish injectables facility that it will market primarily to U.S drugmakers, the company said Tuesday.
The new 60,000-square-foot facility in downtown Grand Rapids will triple GRAM’s manufacturing footprint to more than 100,000 square feet of production space and help level up the company’s sterile injectables offerings, according to a release. The newest fill-finish plant is GRAM’s third, the company said, and its fifth manufacturing facility overall.
In its 10th year in business, GRAM has been able to afford its rapid scale-up through strong growth and its reputation as a high-quality manufacturing partner in the heart of the Midwest, CEO Tom Ross told Fierce Pharma.
GRAM plans to market its new manufacturing space to a stable of existing customers as well as drugmakers looking to “onshore” their manufacturing back on U.S. soil. That strategic direction stems from GRAM’s unique position as an American-made company but also a response to a growing need for domestic contract manufacturers.
“The ability to grow off the same base and focus the culture around quality and service is critical,” Ross said. “The opportunity is there for us to continue to meet that demand.”
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