Brammer Bio Launches Gene-Therapy Product Mfg OperationsBy
Brammer Bio, a Lexington, Massachusetts-headquartered cell and gene therapy contract development and manufacturing organization, has completed renovations and has launched 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 was previously licensed by regulatory authorities to manufacture four commercial protein therapeutic products. The facility houses equipment in cleanroom suites designed to accommodate a range of gene-therapy manufacturing process technologies.
In January 2017, Brammer acquired the Cambridge site from Biogen and on-boarded a team of 100 employees that has expanded to a team of 150. 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 a heating, ventilation and air conditioning system for grade-C cleanrooms, unidirectional flow, and a centralized vaporized hydrogen peroxide system designed to ensure suite sanitization.
The company also acquired a 49,000 square-foot GMP distribution center in Somerville, Massachusetts that provides high-quality storage and clinical and commercial distribution capabilities. In September 2017, Brammer announced the completion of a doubling of its early-phase clinical manufacturing capacity in Alachua, Florida.
Source: Brammer Bio