In response to these challenges, we are continuously evolving our AAV production platform to strike the right balance between quality and productivity, ensuring vectors are consistently manufactured to maintain high quality at larger scales. Achieving these objectives requires working with process developers and technology providers with the same values, who are committed to meeting the goals of each project, including adhering to timelines and continuing to optimise costs and patient accessibility.
How did Ascend develop an AAV platform to support the industry’s needs?
Building forward from expertise as gene therapy developers, the AAV platform at Ascend has been designed to balance high-quality AAV vector yields across different capsid serotypes. Regulatory compliance also remains a core driver. And technology plays the most critical role in the flexibility of the platform. Ascend offers an unmatched in-house and outsourced analytics portfolio. Optimisation of processes can be achieved with the EpyQ™ AAV production system or using traditional triple transfection. Every process is constructed for the needs of the product, rather than trying to force a product into an existing platform process.
What should AAV therapy manufacturers look for in a technology partner?
Technology is a crucial pillar for the development of cell and gene therapies. With a competitive landscape and an increasing number of therapies progressing to clinical stages, developers of AAV-based gene therapies need technologies that can expedite development, COGs, and enhance process robustness. 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.
It is imperative that AAV therapy developers and potential technology partners share the same goal: developing safe, efficient AAV therapies for patients with a quality mindset and reliable communication. Technology providers should also be able to help manufacturers respond flexibly to timelines and provide support in the dynamic and demanding cell and gene therapy field.
To help achieve its goal of bringing safe and effective AAV therapies to its clients and patients, Ascend partners with technology providers with stellar reputations and proven track records. They also select collaborators who continuously evolve their platforms to keep up with the industry’s demands.
Sartorius has worked to establish a position of excellence in the field with support and services for every process step. In 2019, Ascend and Sartorius began partnering. Still in stealth mode, Ascend was initially using the Ambr® 250 multi-parallel bioreactor platform (up to 250mL). Since then, the partnership has strengthened and Ascend has significantly expanded its capabilities to include the Ambr®15 high-throughput system and the Biostat® STR 200 L in their Munich development laboratories. Not only is the range of scalable bioreactor technologies valuable to Ascend, so too is the buffer and media preparation capabilities support Sartorius offers.
Ascend said of the collaboration: “From our experience over multiple years, the team has very good quality oversight of the products, and a high level of timely customer support. We have always maintained a positive partnership with this team and appreciated how they keep us aware of their latest innovations and technologies, including being involved in beta testing of some of their innovative technologies. We look forward to continuing this collaboration for many more years to come.”
