Case Study

Low-Cost, Fast, And Scalable Downstream Purification Process Development For A Clinical-Stage Retrovirus-Like Particle

Source: Bio-Rad Laboratories, Inc.

By Mark Fitchmun

Bioprocess

Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. Here Bio-Rad presents 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 biroeactor harvest and resulted in a 99% reduction in process volume and up to 65% recovery of virus particles with a final purity consistent with requirement for clinical trials. This protocol is 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.