- Cambridge CDMO Brammer Bio expects its gene therapy manufacturing facility will be fully operational by the fourth quarter, less than a year after the company bought the 66,000 square-foot Kendall Square site from Biogen.
- Brammer has been renovating the site, which was originally designed as a biologics production facility, for late-stage clinical and commercial manufacturing of gene therapy products. Brammer also acquired a distribution center in Somerville, Massachusetts and about 100 staff in the January deal with Biogen.
- The CDMO said it had wrapped up a meeting with the Food and Drug Administration to review designs, and plans to submit a site master file later this year.
Gene therapy is beginning to move from brilliant science to commercial markets. Only a few gene therapies — such as GlaxoSmithKline's Strimvelis — have been approved for use and only in Europe. But more are moving through late-stage development at companies like Spark Therapeutics and BlueBird Bio.
Mirroring that development, companies down the supply chain have been investing in commercial-ready manufacturing.
By buying the ex-Biogen site, Brammer acquired a launch pad to expand its commercial capacity and secured space in a coveted Cambridge location, placing it nearby to a slew of gene therapy-focused biotechs.
The previously Florida-based Brammer also now has a site in Lexington, Massachusetts which it plans to use for late-stage and commercial cell therapy supply.
Other contractors have been broadening their capabilities, too. Larger manufacturers like GE Healthcare and the Swiss contracting giant Lonza have recently taken steps to expand their manufacturing capabilities in gene therapy. And smaller firms such as Dimension Therapeutics, Orchard Therapeutics, and Cobra Biologics are also building out capacity in the space.