Brammer Bio announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site in Cambridge, Massachusetts for gene therapy products.
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. The facility houses state-of-the-art equipment in cleanroom suites specially designed to accommodate a broad-range of gene therapy manufacturing process technologies.
"Our Cambridge site underwent a remarkable transformation," said Mark Bamforth, president and chief executive officer 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.
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.