Increasing efficiency in AAV-based gene therapy production: platform optimization with multiserotype AAV affinity capture
Cell & Gene Therapy Insights 2024; 10(5), 747–762
DOI: 10.18609/cgti.2024.090
As the gene therapy field advances, speed-to-market is becoming more and more essential. The necessary reduction in development timelines can be realized by leveraging platform-based tools and technical expertise. Platforms for clinical manufacturing of AAV offer the advantage of a pre-designed template tailored to fast-track products through development and into GMP manufacturing. In addition, design of experiment elution optimization studies can enable advantageous gains in recovery. In this article, an off-the-shelf solution for AAV production developed by a CDMO is introduced, with a particular focus on the AAV capture steps of the downstream process. Case study data is presented to explore the considerations for the use of platform purification tools in AAV manufacturing.