Quality from the start: designing a scalable AAV production platform
Posted: 3 October 2024Scaling of adeno-associated viral (AAV) vector manufacturing processes continues to present numerous challenges to the advance of gene therapy programs into and through the clinic. Ascend believes quality is the critical underlying issue. Development of robust, reproducible, cost-effective processes from the outset is essential to ensuring scalable production of high-quality vectors in high yields and avoidance of expensive and lengthy delays during later development stages. We therefore continuously evolve our AAV production platform to strike the right balance between quality and productivity, ensuring vectors across different capsid serotypes are consistently manufactured to maintain high quality at larger scales.
To develop our AAV platform, we work with process developers and technology providers committed to developing safe, efficient AAV therapies for patients with a quality mindset and reliable communication, adhering to timelines, and optimizing costs and patient accessibility. These collaborations are combined with Ascend’s unmatched in-house and outsourced analytics portfolio, proprietary EpyQ™ AAV production system, and traditional triple transfection technology to meet the specific needs of each client and project. Indeed, integrating the latest technological advancements and novel strategies in AAV chemistry, manufacturing and controls (CMC) is essential to facilitate the advancement of gene therapies for diseases that present complex risk/benefit considerations
Sartorius has been a key technology partner for Ascend since 2019, when it implemented the Ambr® 250 multi-parallel bioreactor platform (up to 250mL). The partnerships have since expanded to include the Ambr 15 high-throughput system, the Biostat® STR 200 L, and buffer and media preparation capabilities support.