Next Gen rAAV Production — A Scalable Platform To Revolutionize Gene Therapy Manufacturing

By Chris Brown, Senior Scientist, Viral Vector Process Development; Yeonji Kim, Senior Research Associate - Bioprocessing; and Xiaojun Liu, Director, Process & Analytical Development

ReciBioPharm has established a robust and scalable rAAV production platform that delivers rAAV8 at concentrations exceeding 2.0E15 GC/L and achieves over 40% full capsids at harvest — among the highest yields reported using transient transfection. By incorporating a novel transfection enhancer and optimizing key upstream process parameters, we have achieved more than a 20-fold increase in rAAV yield and a 3-fold improvement in % full capsids compared to traditional transient transfection methods.

Using a design of experiments (DOE) approach, we identified optimal conditions for transfection, including cell density, enhancer concentration, DNA quantity, and DNA-to-transfection reagent ratios. This optimization further enhanced rAAV yield and quality. Additionally, we successfully scaled this process using single-use bioreactor systems.

This advanced platform represents a significant step forward in rAAV manufacturing, offering higher yields, lower production costs, and accelerated timelines for drug development.