In October, CRB, a provider of project delivery solutions for vaccine and critical therapy manufacturers, completed the design and construction of a large-scale facility for Grand River Aseptic Manufacturing (GRAM). GRAM has been selected by the U.S. government to increase domestic pharmaceutical manufacturing for vaccines or therapeutics against COVID-19.

GRAM's new 60,000 sq.-ft. facility in Grand Rapids, MI was built using CRB's ONEsolution project delivery method, and is one of three GRAM manufacturing facilities. The newest facility was designed to increase GRAM's large-scale fill and finish capacity with room to expand as demand grows.

CRB's ONEsolution project team optimized delivery and phasing for GRAM, allowing for fast-tracked procurement, planning, and construction. CRB and GRAM completed the facility on-schedule and on-budget.

As a U.S.-based CDMO, GRAM supports the pharmaceutical supply chain by offering state-of-the-art equipment and providing the capacity to perform advanced aseptic fill and finish services – the last two steps in the manufacturing process for vaccines or therapeutics. GRAM's facilities will support the U.S. government and help position the nation's supply chain to handle future public health emergencies.

In September, GRAM entered into an agreement with Janssen Pharmaceuticals, one of the Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine candidate, including technical transfer and fill and finish manufacture.

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) of the U.S. Department of Health and Human Services.

John Wichelt, Vice President of Client Pharmaceutical Services at Grand Rapids Aseptic Manufacturing and Jesse Adams, Senior Project Manager at CRB discuss how this facility got ramped up to prepare for production. –KB

Contract Pharma: How much manufacturing capacity did GRAM take on as a result of the BARDA contract?

John Wichelt: Grand River Aseptic Manufacturing (GRAM), was selected by the U.S. Department of Health and Human Services and the U.S. Department of Defense to support the expansion of the United States’ capacity for manufacturing and distributing vaccines or therapeutics related to the COVID-19 pandemic. Through this public-private partnership, the federal government is reserving fill/finish capacity on a commercial filling line for use by federal partners that are developing COVID-19 vaccines or therapeutic treatments. GRAM’s capacity not only supports the U.S. government’s Operation Warp Speed efforts and the COVID-19 pandemic response, but also increases U.S. preparedness for future public health emergencies.

CP: What was involved in ramping up the facility to prepare for production?

JW: The GRAM team accelerated their facility readiness by implementing a multi-phased qualification approach, simulated media fills, and sped up validation efforts through the use of validation contractors.

CP: What are some of the key attributes in the design of this fill/finish facility?

JW: Using the design-build method, the GRAM team was able to decide on the equipment and build the facility around our needs that would best serve our clients and future clients. The facility was built for flexibility to manufacture many different types of products and was designed with the employees and clients in mind as well.

CP: What does CRB’s ONEsolution project delivery method entail?

Jesse Adams: ONEsolution is CRB’s trademarked integrated project delivery method that provides clients with complete design and construction services from initial planning through operational readiness in a safe, lean and collaborative way. When compared to typical delivery methods, ONEsolution has proven to allow for earlier cost certainty, more condensed schedules and higher quality facilities.