2022RFP0032 - Scalable Viral Vector Filter and Concentration System

The University of Calgary (UCalgary) is requesting proposals for a scalable filter and concentration system that separates vectors from bioreactor-derived suspension cells and debris. 
Overview: 
Lentiviral vectors (LV) are the most common delivery method for transducing T cells for CAR T cell therapies. LV production and purification are major cost drivers in CAR T manufacturing, with an industry ‘gold standard’ of 20% to 40% recovery. This poor overall recovery leads to oversized and expensive production batches. The first step of purification, physically segregating LV from the cells from which they are produced, remains a serious challenge.

Our goal is to use a scalable filter and concentration system to remove producer cells, debris, and large aggregates from the LV prep.

The workflow we are looking to achieve would include the following. Lentiviral vector is collected from upstream manufacturing (we currently have in place). First step is clarification, which includes removing cellular debris through normal flow filtration (NFF). Next is ultrafiltration/diafiltration (UF/DF), which concentrates the virus and exchanges the buffer using tangential flow filtration (TFF). Followed by chromatography for viral purification and polishing. Finally, a TFF step for formulation and additional concentration of the virus.