Viral Vector Downstream Processing

Demand for new gene therapies is challenging manufacturers to seek new ways of accelerating product development and production. Purification processes have historically been based on legacy systems used for monoclonal antibody (mAb) production, requiring large capital and labor investments. The introduction of new technologies for gene therapy production offers the opportunity to increase yield and throughput.

Examples include:

• Ultrafiltration/diafiltration operations, particularly with the use of tangential flow filtration (TFF) for cell or viral harvesting and purification, downstream protein concentration and diafiltration, as well as in final formulation
• Intensified chromatography processes that reduce the number and size of unit operations, via technologies such as high-productivity, single-use chromatography membrane adsorbers

In many documented instances these new downstream technologies have shortened virus purification times from hours to minutes, while at the same time improving product recovery. The result is a cost-effective response to difficult competitive trade-offs, enabling gene therapy manufacturers to achieve easier scalability, a reduced process footprint, and more efficient facility utilization.