Sarepta Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company focused on RNA-targeted therapeutics for rare neuromuscular diseases, has formed a long-term manufacturing partnership for gene-therapy with Brammer Bio, a Lexington, Massachusetts-headquartered cell and gene-therapy contract development and manufacturing organization.

Brammer Bio will provide Sarepta access to clinical and commercial manufacturing capacity for Sarepta’s micro-dystrophin Duchenne muscular dystrophy (DMD) gene-therapy program and a manufacturing platform for future gene-therapy programs, such as for limb girdle muscular dystrophy.

Sarepta has adopted a hybrid internal and external development and manufacturing model. Under this model, Sarepta is expected to continue to build internal knowledge in all aspects of adeno-associated virus-based manufacturing while externally Brammer Bio will provide scalable manufacturing capabilities. The collaboration model will integrate process development, clinical production and testing, and commercial manufacturing.

Brammer Bio is partnering with Sarepta to design and build commercial manufacturing capacity within Brammer Bio’s facility. Once complete, the facility is expected to provide manufacturing capacity to support the demands for systemic administration of the micro-dystrophin therapy for DMD.

Brammer Bio’s 74,000-square-foot early clinical campus consists of three buildings in Alachua, Florida, comprised of a process development and analytical development facility, adjacent to its cGMP Phase I/II 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. The company also has 165,000-square-feet of combined facility space in Massachusetts for Phase III and commercial cGMP viral-vector manufacturing. The facility located in Cambridge, Massachusetts was built out late in 2017, and the facility in Lexington, Massachusetts will be operational in 2019. Both are supported by the warehouse and distribution center in Somerville, Massachusetts.

Source: Sarepta Therapeutics