Biopharma Sarepta Therapeutics is partnering with Brammer Bio to design and build new manufacturing capabilities at the CDMO’s plant in Lexington, Massachusetts, for the production of its microdystrophin Duchenne muscular dystrophy (DMD) therapy and future gene therapies.
The cost of the project is estimated to be about $100 million, which will be borne equally, a spokeswoman for the two companies told FiercePharmaManufacturing. The project is expected to be completed next year.
Under a hybrid internal and external development and manufacturing model, Sarepta will continue to build internal expertise in all aspects of AAV-based manufacturing, while Brammer Bio will provide scalable manufacturing capabilities, the companies said.
The partnership will integrate process development, clinical production and testing, and commercial manufacturing with the goal of bringing microdystrophin gene therapies to patients. Once complete, the new facility is expected to provide manufacturing capacity to support the unusually high demands typical for systemic administration of the microdystrophin therapy for DMD, they said.
“Our hybrid approach enables us to leverage both our internal expertise and capabilities and Brammer Bio’s capacity and expertise, allowing for minimal changes to the process to accelerate therapies for patients with DMD and LGMD (Limb girdle muscular dystrophy),” Doug Ingram, Sarepta’s president and CEO, said in a statement.
Brammer Bio was formed in March 2016 through the merger of Brammer Biopharmaceuticals and Alachua, Florida-based Florida Biologix, with the help of a capital infusion from Ampersand Capital Partners, Florida Biologix's majority owner.