For revolutionary gene therapies to reach their full therapeutic potential, high throughput process development workflows are needed to keep pace with the ever-changing landscape of capsids and payloads. In addition, many of the current analytical testing methods are either not able to match the pace of process development, use too much material, or are inherently unsuited to support various unit-operations. As a result, they become a bottleneck to these essential therapies reaching the clinic in a timely manner.
The development of robust fit-for-purpose analytical platforms must match the pace of innovation the industry is seeing. While we continue to discover the broad applications of the various AAV serotypes, their distinct biological properties require tailored, stage-appropriate analytical methods. These methods must be able to provide higher resolution, while also using less material or providing novel insights to keep pace with the ever-increasing speed of process development activities.