Grand Rapids, Mich., April 28, 2021 /PRNewswire/ -- Grand River Aseptic Manufacturing ("GRAM"), a leading injectable contract development and manufacturing organization ("CDMO"), was awarded the 2021 Facility of the Year Award for Special Recognition of Operational Agility: COVID-19 by the International Society for Pharmaceutical Engineering (ISPE). GRAM received the distinction for the design and efficacy of its 60,000 sq. ft., world-class, large-scale fill/finish facility in downtown Grand Rapids, Michigan.
GRAM designed the fill/finish facility from the ground up with a focus on safety, capacity, and flexibility. Employee safety, exceeding regulatory requirements, and client needs stayed at the forefront by choosing best-in-class technology and facility design solutions first, then building the facility around to support. One-way material and people flows were incorporated to ensure product integrity, client viewing rooms with windows directly into formulation and fill suites were included for transparency, top of the line equipment was installed to provide flexibility, and Current Good Manufacturing Practices (CGMP) to serve a variety of client needs. The West Michigan CDMO overcame geographical challenges and fast-tracked the project to complete construction months ahead of schedule. This accelerated timeline enabled GRAM to open the pharmaceutical manufacturing facility in June 2020 at the height of the COVID-19 pandemic, leading to a contract with Operation Warp Speed and Johnson & Johnson.
"This year's FOYA recognition from ISPE is a testament to GRAM's employees and their tremendous dedication that completed our world-class facility at a time when there was much at stake for our country," said GRAM President and CEO Tom Ross. "It is truly remarkable what our team has accomplished. We are fortunate to have passionate team members that excel at problem solving and decision making that leads to successful projects. I am thrilled to share this honor with the entire GRAM team."
Currently, GRAM's fill/finish facility is supporting New Brunswick-based Johnson & Johnson COVID-19 vaccine production. GRAM sped up operational readiness by six weeks to provide fill/finish services for Johnson & Johnson's COVID-19 vaccine at its new facility. To further increase capacity, GRAM has invested in adding 18,000 sq. ft. to the facility, a duplicate Bausch+Ströbel vial filler with SKAN Isolator technology, and a VarioSys® syringe and vial filler which are set to arrive in early 2022 to further increase capacity and serve clients with advanced technology.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. ("GRAM"), a modern parenteral contract development and manufacturing organization, delivers customized solutions to meet clients' fill and finish needs from development through commercialization. With capabilities for biologics, small molecules and vaccines, GRAM's advanced technology and nimble staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
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About the ISPE Facility of the Year Awards Program
Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.