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Fast-track design and construction of CDMO facility
When contract development and manufacturing organization (CDMO), Grand River Aseptic Manufacturing (GRAM), made the business decision to triple their production space, they turned to CRB.
The highly regarded CDMO has experienced rapid growth and wanted a fast-tracked schedule. They chose CRB for our ability to meet their desired deadline with our ONEsolution™ project delivery method. Breaking ground in October 2018, the 60,000-square-foot facility was built in just 20 months.
Grand River Aseptic Manufacturing
Grand Rapids, Michigan
A process-first approach is one of three elements that make up ONEsolution™. It means we design facilities from the inside out, and it requires a deep understanding of our clients’ processes and business challenges.
By deciding on equipment and layout first, then building the facility around it, GRAM could focus on their purpose for the expansion—meeting the demand for high-quality aseptic fill-finish products. This could only be done with a design team that is deeply knowledgeable about the current pharmaceutical market trends.
State-of-the-art equipment and design
The facility is home to industry-leading equipment for fill and finish facilities including a fully integrated, high-speed Bausch+Ströbel filling line, IMA LyoMax 17 Lyophilizer and SKAN Isolators.
CRB strives to include prefabrication, preassembly, modularization and offsite construction (PPMOF) solutions on each of our projects. In this case, PPMOF wasn’t just a sustainability goal, it was a necessity to meet the tight schedule.
GRAM’s project site required soil stabilization prior to any construction activities. During stabilization activities, CRB had the isolated spread footings for foundation formed and cast offsite. When the project site was properly stabilized and safe for construction activities, the footings were brought in and installed in a matter of hours. A conventional installation of isolated spread footings would have taken two to three weeks.
Room for additional expansion
The facility and equipment upgrades allow GRAM to offer high-speed manufacturing for all commercial batch sizes. Formulation volumes increased to 1,000 liters, filling up to 200 vials per minute, lyophilization capacity to 68,000 vials, and there’s still room for further production expansions.
CRB designed the facility with flexibility and future expansions in mind. There’s space for additional clean rooms and equipment to continue supporting the growing demand for US-based pharmaceutical manufacturing.