Manufacturing a Recombinant Retrovirus — Downstream Purification Process Development

Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. This webcast details the importance of resin screening, endonuclease treatment, process development, and the scale-up purification of a retrovirus-like particle intended for use in human subjects. The resulting current good manufacturing practice (cGMP)–compatible process required approximately four 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 process using Nuvia Q Anion Exchange Resin, 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.