Brammer invests in commercial-ready gene therapies
The contract development and manufacturing organization (CDMO) said the site offers process development, clinical phase, and current Good Manufacturing Practices (cGMP) services for cell and gene therapies.
“We are delighted to add an experienced commercial biologics team and facilities to help meet the needs of this transformative industry,” said Mark Bamforth, CEO of Brammer.
Brammer has completed a Type-C meeting with the US Food and Drug Administration (FDA) to assess the plans for the Massachusetts-based site. A Type-C meeting regards the development and review of drugs or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
A Site Master File will be submitted later this year to support Brammer’s clients’ product applications.
The site originally housed Biogen’s clinical and commercial biologics manufacturing facility.
Brammer purchased it along with Biogen’s distribution center in Somerville, Massachusetts, on January 1, 2017.
The Somerville site offers Brammer nearby storage and distribution capabilities.
The announcement follows Brammer’s 2016 plans to renovate its 50,000 square-foot facility in Lexington, Massachusetts, to cater for late stage and commercial therapy supply.
Brammer’s facilities now offer 230,000 square feet of development, distribution and cGMP manufacturing capabilities across Florida and Massachusetts, US.
