Abstract

Gene therapy holds the potential to revolutionize the treatment of a wide range of diseases, but scalable and cost-effective manufacturing remains a significant challenge. In this keynote, I will explore how innovative chromatography technologies—specifically Radial Flow Chromatography and Sepragen's QuantaSep DSP system—are transforming viral vector purification to support the rapid growth of gene therapy.

The QuantaSep DSP integrates buffer blending and chromatography in a single system, dramatically reducing the need for buffer preparation, saving both time and costs, and reducing space requirements. This system is designed to enhance scalability and throughput, allowing manufacturers to meet the increasing demand for viral vectors in a more efficient, cost-effective manner.

Through the use of Radial Flow Columns, the system provides faster flow rates and higher capacity, improving the overall productivity and consistency of viral vector purification.

These advancements make the technology ideal for both clinical-scale development and commercial manufacturing, supporting gene therapy companies in their journey from development to clinical application.

The presentation will highlight the impact of these technologies on AAV and lentivirus production, showcasing real-world examples of how they streamline process development, reduce contamination risks, and ensure compliance with cGMP standards. Additionally, I will discuss the broader implications of these innovations in advancing the field of gene therapy and accelerating the delivery of life-saving treatments.