Sarepta Enters into Manufacturing Partnership with Paragon Bioservices
Sarepta Therapeutics announced that it has entered into a long-term strategic manufacturing partnership with Paragon Bioservices (Paragon), which will provide Sarepta access to additional commercial manufacturing capacity for its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program, as well as a manufacturing platform for future gene therapy programs, such as Limb-girdle muscular dystrophy (LGMD).
“We are rapidly building a formidable gene therapy engine, the hallmark of which will be the establishment of our Gene Therapy Center of Excellence in Columbus, Ohio. Therefore, it is incumbent upon us to ensure that our ambition is matched with a sophisticated, robust and scalable manufacturing approach that can accelerate a steady stream of gene therapies to treat life-robbing genetic diseases for the near and long-term,” stated Doug Ingram, Sarepta’s president and chief executive officer.
Mr. Ingram continued, “Consistent with our hybrid manufacturing strategy, we are proud to welcome Paragon, a preeminent global biomanufacturer with a proven track record and expertise in the complex field of biotherapeutic manufacturing, to our coalition of the world’s leading gene therapy organizations. Our partnership with Paragon provides additional scalable capacity for our micro-dystrophin program and our future programs, which currently include Duchenne, LGMD, Pompe, and CNS. Our partnership also grants Sarepta access to Paragon’s world-class team, some 300-plus strong, whose varied expertise we can draw upon as we continue on our path to becoming among the most meaningful genetic companies in the world.”
“Paragon is one of the few gene therapy manufacturers that has the expertise to develop and successfully manufacture complex biotherapeutics using commercially-scalable processes,” said Pete Buzy, Paragon Bioservices President and CEO. “As this agreement with Sarepta highlights, we have a world-class manufacturing team, we are seen as a center of excellence for gene therapy, and we are trusted by top biopharmaceutical companies.”
Paragon, one of Baltimore’s largest biotechnology companies, employs a team of 300+ at two locations in Maryland. Paragon is constructing a new, world-class, 151,000 square-foot, GMP gene therapy biomanufacturing facility, which will be online in February 2019 and is located in Anne Arundel County. It will include several 500L and 2000L single-use bioreactors for clinical trial and commercial material production. Paragon also has facilities at the University of Maryland, Baltimore (UMB) BioPark where the Company currently provides full process, analytical development, and cGMP clinical manufacturing services from its approximately 100,000 square-foot facility. The BioPark facility complies with both European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) early-phase manufacturing requirements for biopharmaceutical manufacturing. The newly constructed facility is being built to comply with these regulations, as well.