Automation In Analytics: Streamlining And Enhancing Gene Therapy Production

By Michael Born, Senior Scientist, Analytical Development

Establishing an analytics program early clinical development is crucial to mitigating risk and accelerating timelines as a gene therapy moves from preclinical to later phases. These complex therapeutics require a comprehensive, balanced analytical program to afford development teams necessary insights while effectively managing resources. A well-designed analytics approach, established early, can help operators better measure the critical quality attributes (CQAs) of a therapeutic, drive optimization, and enable compounding benefits for downstream yields and product quality.

While some gene therapy innovators set up in-house analytics, others opt to partner with contract development and manufacturing organizations (CDMO) that offer the expertise, capabilities, and experience to establish an analytics approach that prioritizes critical assays that can serve to drive insights and inform near real-time decision-making. With either approach, gene therapy innovators will benefit from a data-driven, collaborative analytics protocol that can enable stronger modeling and higher confidence as the program scales. These analytical methods can be further streamlined through automation aimed at reducing hands-on processing and enabling the high-throughput testing needed to accelerate development.