Demonstration On Scalability Of A Flexible, High-Producing Triple-Transfection rAAV Platform

Recombinant adeno-associated virus (rAAV) has emerged as a pivotal vector for delivering DNA to target cells, with applications spanning a variety of genetic therapies. ReciBioPharm has developed a scalable and high-producing rAAV platform to address the increasing demand for gene therapy vectors. This triple-transfection method, despite being one of the more costly production processes, provides significant flexibility in product generation and streamlined development timelines.

This platform is designed to deliver high yields of rAAV with consistent quality, making it suitable for both small-scale and large-scale production. In this study, we demonstrate the scalability of our platform from a 2L benchtop bioreactor to a 50L pilot-scale single-use bioreactor, achieving harvest yields exceeding 1.6E15 GC/L with over 40% full capsids. This robust and versatile process supports various capsid serotypes, transfection reagents, and transgenes, highlighting its broad applicability. Our platform's high titer and reduced manufacturing costs position it as a cost-effective solution for producing gene therapy vectors.