Brammer Bio, Sarepta Enter Long-term Mfg. Tie-up

Sarepta Therapeutics, a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, has entered into a long-term strategic manufacturing partnership with Brammer Bio, which will provide Sarepta access to clinical and commercial manufacturing capacity for its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program and a manufacturing platform for future gene therapy programs, such as Limb girdle muscular dystrophy (LGMD).

Sarepta has adopted a hybrid internal and external development and manufacturing model. Under this model, Sarepta will continue to build internal expertise in all aspects of AAV-based manufacturing while externally Brammer Bio will provide scalable best-in-class manufacturing capabilities. The collaboration model will integrate process development, clinical production and testing, and commercial manufacturing with the goal of bringing micro-dystrophin gene therapies to the patient community urgently and in sufficient supply.

Brammer Bio will partner with Sarepta to design and build dedicated commercial manufacturing capacity within their facility with cutting-edge capabilities. Once complete, the facility is expected to provide robust manufacturing capacity to support the unusually high demands typical for systemic administration of the micro-dystrophin therapy for DMD.

"As we have stated in the past, Sarepta is committed to becoming one of the most meaningful genetic medicine companies in the world over the coming few years," said Doug Ingram, president and chief executive officer, Sarepta. "The Brammer Bio partnership and dedicated gene therapy capacity, once complete, will represent more annual gene therapy supply than any currently existing facility.

"At Sarepta, we pride ourselves in partnering with the best and brightest to advance our mission. With that in mind, we are proud to have selected Brammer Bio as our partner because they are among the world's most advanced cGMP gene therapy manufacturers, with expertise that spans all aspects of AAV-based gene therapy development, manufacturing and release. 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." 

"Brammer is delighted to partner with Sarepta Therapeutics to use our team's deep development, clinical and commercial expertise to support the rapid development of Sarepta's gene therapy products to serve patients in the United States and globally," said Mark Bamforth, president and chief executive officer, Brammer Bio.

Brammer Bio's team of more than 400 employees operates in Massachusetts and Florida. The 74,000 square-foot early clinical campus consists of three buildings in Alachua, FL, comprised of a process development and analytical development facility, adjacent to its cGMP Phase 1/2 clinical manufacturing operation with a third warehouse and office building. Brammer Bio's cGMP facility has been supporting gene therapy clinical development for 12 years at this location.

Brammer Bio has 165,000 square-feet of facilities in Massachusetts for Phase 3 and commercial cGMP viral vector manufacturing. The facility located in Cambridge was built out late in 2017 and the facility in Lexington will be operational in 2019; both are supported by the warehouse and distribution center in Somerville.