Low-Cost, Fast, and Scalable Downstream Purification Process Development for a Clinical-Stage Retrovirus-Like Particle

Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. Here we present a case study about resin screening, process development, and scale-up purification of a retrovirus-like particle. The resulting cGMP- compatible process required approximately 4 hours to purify 240 L of nuclease-treated bioreactor harvest and resulted in a 99% reduction in process volume and up to 65% recovery of virus particles with a final purity consistent with requirements for clinical trials. This protocol is readily scalable, fast, low cost, simple, and cGMP-compatible and can be used for the capture step in clinical-grade manufacture of retrovirus vectors. Learn More