Brammer Bio, a best-in-class cell and gene therapy contract development and manufacturing organization (CDMO), announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site in Cambridge, Massachusetts, USA, for gene therapy 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.
“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.”
The site’s launch demonstrates Brammer’s end-to-end CDMO services from early phase process development through commercial manufacturing. The Brammer team consists of over 300 extraordinary employees focused exclusively on serving the cell and gene therapy needs of its clients and their patients.