As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require “viral clearance” validation studies for each biopharmaceutical prior to approval. For example, 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…

In October 2022, a new draft of ICH Q5A (R2) was released, the first such update in more than 20 years. This draft revision was necessary to reflect current scientific knowledge and biotechnology advances such as new product types that are amenable to viral clearance and alternative virus clearance validation strategies. In this report, we delve into the evolving landscape of viral clearance practices, focusing on the implementation of continuous manufacturing, advancements in study design, and the implications for cell…