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Agreements

Date: 2017-11-27

Type of information: Opening of new premises

Compound: manufacturing site in Cambridge

Company: Brammer Bio (USA - MA)

Therapeutic area: Technology - Services

Type agreement: opening of new premises

Action mechanism: gene therapy

Disease:

Details:

  • • On November 27, 2017, Brammer Bio, a 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 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. 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. Now, 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 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.
 

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