Brammer Bio, a best-in-class cell and gene therapy contract development and manufacturing organization, completed renovations and opened its late-stage clinical capacity and commercial-ready cGMP manufacturing site, designed for gene therapy products, in Cambridge, Massachusetts.
The facility houses state-of-the-art equipment in cleanroom suites specially designed to accommodate a broad-range of gene therapy manufacturing process technologies.
The 66,000 square-foot Cambridge facility in the heart of Kendall Square was previously licensed by regulatory authorities to manufacture four commercial protein therapeutic products.
"Our Cambridge site underwent a remarkable transformation," said Mark Bamforth, President & CEO of Brammer. "We converted the former biologics manufacturing space that once produced some of the first antibody-based therapies into a facility that now produces leading edge gene therapy products using a variety of manufacturing platforms."
In January 2017, Brammer acquired the Cambridge site from Biogen and on-boarded an experienced team of 100 employees that has expanded to a team of 150.
Today, the facility includes multiple drug substance suites able to support large-scale adherent and stirred tank production, an automated fill/finish system leveraging isolator technology, quality control laboratories, and process development space. The facility is designed with HVAC system for grade C clean rooms, unidirectional flow, and a centralized vaporized hydrogen peroxide system to ensure suite sanitization.
"Our success is founded on our team's strong scientific and manufacturing expertise," said Christopher Murphy, Chief Manufacturing Officer at Brammer. "That foundation is supported by Brammer's investment of over $50 million in expanding its CDMO services. Today, we offer clients access to capacity at a variety of scales, and with a personalized manufacturing approach that is focused on safety, quality, process robustness, and fulfillment of their product goals."
According to company officials, the site's launch demonstrates Brammer's end-to-end CDMO services from early phase process development through commercial manufacturing. The company also acquired a 49,000 square-foot GMP distribution center in Somerville, Massachusetts, providing high-quality storage and clinical and commercial distribution capabilities. In September of this year, Brammer announced the completion of a doubling of its early phase clinical manufacturing capacity in Alachua, Florida.