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Brammer Bio Achieves Milestone

05.11.17

Establishes commercial-ready gene therapy supply for the industry

Brammer Bio, a cell and gene therapy contract development and manufacturing organization (CDMO), says it is on-track to complete the establishment of commercial-ready gene therapy manufacturing capacity in Cambridge, MA, in the second half of 2017. This follows the January 1, 2017 acquisition of Biogen's biologics manufacturing facility in Cambridge and distribution center in Somerville, MA, that included the on-boarding of an experienced team of 100 employees. Further, Brammer completed an FDA Type-C meeting to review the design plans for the Cambridge facility and will submit a Site Master File later this year to support its clients' product applications.

Brammer now offers a complete range of process development, clinical phase, and Current Good Manufacturing Practices (CGMP) services for cell and gene therapies using multiple platform technologies.

"We are delighted to add an experienced commercial biologics team and facilities to help meet the needs of this transformative industry," said Mark Bamforth, president and chief executive officer, Brammer. "We are building on more than a decade of supplying first-in-human cell and gene therapy clinical trials under the leadership of Dr. Richard Snyder, Brammer's chief scientific officer. Our commercial-ready Cambridge facility will be fully operational by Q4 2017. We appreciate Biogen's support during the transition of the facilities and skilled manufacturing personnel."

Originally built for the manufacture of Biogen's clinical and commercial biologics, the 66,000 square-foot Cambridge facility in the heart of Kendall Square was licensed by regulatory authorities to manufacture four commercial products. Brammer is renovating the facility for late-stage clinical development and commercial launch of gene therapy products. Brammer also acquired Biogen's nearby 49,000 square-foot, state-of-the-art distribution and warehousing facility, providing high-quality storage and distribution capabilities.