BPI Contributor

September 22, 2023

20 Min View
The Use of Retrovirus-Like Particles (RVLP) to Evaluate Viral Clearance in Downstream Processing

Date: Sep 22, 2023

Duration: 20 Min

This webcast features: David Cetlin, Senior Director, MockV Products, Cygnus Technologies.

Type C Retrovirus-Like Particles (RVLP) are endogenously produced during CHO cell expression. As such, regulatory agencies require proof that downstream process steps can effectively remove or inactivate retrovirus. A model mammalian virus, Xenotropic Murine Leukemia Virus (XMuLV) is typically used to demonstrate RVLP clearance. However, the establishment of RVLP quantification methods has made it possible to track the removal of actual endogenous RVLP throughout the downstream process. Additionally, the recent draft of ICH Q5A revision states that, “For CHO cell-derived products, CHO-derived endogenous virus particles (RVLP) can also be used for viral clearance experiments.”

In this webinar, we will demonstrate how a highly concentrated and purified stock solution of CHO-derived RVLPs has been used as a BSL-1 compatible spiking agent for viral clearance studies. Data comparing the log reduction values derived from RVLPs vs XMuLV over multiple modes of separation, including Protein A, virus filtration, CEX, AEX, and mixed-mode chromatography will be presented. In addition, we developed a facile method of inactivating and quantifying the detergent inactivation of RVLPs.

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