Manufacturing
Building the right expertise to prepare for scalability to support the company’s deep pipeline
Sarepta's Manufacturing Strategy
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:
- Move rapidly through development
- Leverage the expertise and capacity of world-class partners
- Support the development and manufacturing of multiple products in parallel
- Adapt approaches to accommodate pipeline growth
- Remain cost-effective
The Complexities of Gene Therapy Manufacturing
Learn more about what goes into manufacturing gene therapies and Sarepta’s approach to meeting the challenges inherent in making these transformative therapies a reality for patients with rare diseases.
Sarepta’s Hybrid Approach - Gene Therapy Manufacturing
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 Internal Expertise
Sarepta’s approach affords the Company control over the most differentiated aspects of manufacturing, as well as providing for speed, scalability, and risk mitigation.
Sarepta’s External Partnerships
Sarepta’s internal expertise and capabilities are complimented by its external partnerships. This hybrid approach is designed to drive competitive costs and enable continuous improvements. Our partners include plasmid supplier, Aldevron; Catalent performs our drug substance and drug product manufacturing utilizing capacity and personnel dedicated to Sarepta; and PPD conducts analytic testing, employing dedicated personnel to support Sarepta’s programs.
