Analytical Methods for Viral Vector Development and Manufacturing in Gene Therapy
Automation of Assays for Gene Therapy Products
What’s in the eBook
Gene Therapy is one of the most innovative therapies in the world. By Q4 2022, there were 24 gene therapies approved (5 of which happened in 2022) and more than 2,000 clinical trials being conducted worldwide (including genetically-modified cell therapies)1.
As with any other therapeutic product, the development and manufacturing of viral vectors for gene therapy must follow Good Practice (GxP) regulations. A Good Manufacturing Practice (GMP)-compliant process for viral vectors must ensure consistent quality in the vector’s potency (biological activity), purity (absence of contaminants or impurities), and safety (absence of potentially harmful substances). To achieve this, various “Critical Quality Attributes (CQAs)” are monitored during the manufacturing process by measuring key properties and ensuring that they are within the appropriate levels2.
Quick, reliable, and high-throughput analytical methods to assess these CQAs are essential in process development and later GMP-compliant testing for batch release during Quality Control. Given that automated liquid handlers dramatically improve results’ reproducibility and samples’ traceability, they are inherently suitable for high-level regulatory compliance.
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1. American Society of Gene + Cell Therapy. 2022. Gene, Cell, & RNA Therapy Landscape Q4 2022 Quarterly Data Report. [Online] Available at <https://asgct.org/publications/news/january-2023/asgct-citeline-q4-2022-gene-therapy-landscape-repo> [accessed 2023 March 16].
2. Gimpel AL, Katsikis G, Sha S, Maloney AJ, Hong MS, Nguyen TNT, Wolfrum J, Springs SL, Sinskey AJ,...Braatz RD. 2021. Analytical Methods for Process and Product Characterization of Recombinant Adeno-Associated Virus-Based Gene Therapies. Molecular Therapy: Methods & Clinical Development. 20:740–754. doi:10.1016/j.omtm.2021.02.010
2. Gimpel AL, Katsikis G, Sha S, Maloney AJ, Hong MS, Nguyen TNT, Wolfrum J, Springs SL, Sinskey AJ,...Braatz RD. 2021. Analytical Methods for Process and Product Characterization of Recombinant Adeno-Associated Virus-Based Gene Therapies. Molecular Therapy: Methods & Clinical Development. 20:740–754. doi:10.1016/j.omtm.2021.02.010