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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
Business case first
Focusing on the business case first is one of three principles that make up ONEsolution™. It means we start with the “why.” This approach positions the team to design and build a facility that not only supports the people and processes, but fundamentally aligns with the business needs for which it was created. Focusing first on the business case brings value and innovation during the project and provides flexibility for many years to come.
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.
ISPE Facility of the Year Award
This facility has been recognized by ISPE with a special recognition award for operational agility in response to the COVID-19 pandemic. “The judging committee recognized that agility as an engineering value driver is getting increasingly important, and in a year where the promise of therapies and vaccines provided much-needed hope for the broader community, GRAM’s sense of urgency and, commitment to creative project execution and collaboration are commendable. The facility design reflects the flexibility, the speed, and the operational agility that ISPE believes are critical to continue driving our collective value.”