Sarepta Therapeutics, a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, 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.
Brammer Bio (USA) provides clinical and commercial supply of viral vectors for in vivo gene and ex vivo modified-cell based therapies, process and analytical development, and regulatory support, enabling large pharma and biotech clients to accelerate the delivery of novel medicines to improve patient health. Brammer Bio’s team of 400+ operates in Massachusetts and Florida.
Sarepta Therapeutics is a US medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts. The company is focused on developing first-in-class, RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases.