Sarepta’s goal is to build the largest gene therapy manufacturing capacity in the industry through a differentiated hybrid model: investing in our own internal expertise and capabilities and establishing flexible working relationships and dedicated capacity with our strategic partners.
Sarepta’s capabilities span from early development to technology transfer. Within the Company, we’ve built the talent and competencies around highly valuable, differentiated process development, analytical development, quality control and assurance, and pre-clinical manufacturing.
And we’ve entered into long-term partnerships for large-scale supply, allowing us to move rapidly from conception to commercialization. Our flexible manufacturing strategy will enable us to meet the needs of our growing pipeline by efficiently developing state of the art technical capabilities.
Our internal expertise combined with our external partnerships allows Sarepta to:
Sarepta’s approach affords the Company control over the most differentiated aspects of the manufacturing process, as well as providing for speed, scalability, and risk mitigation.
Reed Clark, PhD, our Vice President of Early Process Development and Analytical Development, is an expert on gene therapy process development and AAV biology—he’s a pioneer in developing manufacturing processes for cell and gene therapies. Hear from Dr. Clark about the complexities and challenges of gene therapy manufacturing, and Sarepta’s approach.
Sarepta’s 80,000 square foot Gene Therapy Center of Excellence in Columbus, Ohio, is the newest addition to our manufacturing network, which includes locations in Cambridge, Massachusetts; Burlington, Massachusetts; and a 38-acre facility in Andover, Massachusetts. We also have a dedicated manufacturing facility within Thermo Fisher, which is located in Lexington, Massachusetts.
In addition, Sarepta has more than 400 employees dedicated to manufacturing, including our partners mentioned above, plus Catalent, Novasep, and the Company’s plasmid supplier, Aldevron.