High-throughput process & analytical platforms to accelerate gene therapy scale-up

Cell & Gene Therapy Insights 2023; 9(8), 933–945


Published: 28 September
Innovator Insight
Patrick Starremans, Kenneth Warrington, Nithya Jesuraj

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 unable to match the pace of process development, use too much material, or are inherently unsuited to support various unit operations. 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 which are able to provide higher resolution using less material, and provide novel insights to keep pace with the ever-increasing speed of process development activities.