Viral Clearance in the Age of Q5A(R2) and the Case for Utilizing Non-Infectious Spiking Agents

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Webinar Date/Time: Thu, May 16, 2024 11:00 AM EDT

Non-infectious mock virus particles that mimic the physicochemical properties of live infectious viruses can be used as spiking agents during viral clearance testing. According to the revised Q5A(R2), “For CHO cell-derived products, CHO-derived endogenous virus particles [RVLP] can also be used for viral clearance experiments.

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Event Overview:

To determine viral clearance efficacy of biomanufacturing steps, viruses are “spiked” into in-process solutions, processed and analyzed for reduction. Due to the infectivity of these viruses, studies are conducted in BSL-2 facilities. Costs and logistics limit analysis during process development. The revised Q5A(R2) guidelines which govern the biotechnology industry on the topic of viral safety and evaluation provide an update to the regulatory stance on viral safety including the use of “Prior Knowledge”. This concept of “Prior Knowledge” can be leveraged to reduce the dependence and scope of CRO-led viral clearance validation studies for a specific biological drug. Much data is required to establish a basis for its justification. Cygnus Technologies, through the MockV® product line, offers solutions that ease the accumulation of viral clearance data. Supplementing a company’s existing prior knowledge with MockV® derived clearance data could effectively reduce the scope and/or need of conducting process-specific live viral validation spiking studies. Discussed in the presentation are results from several studies that utilized CHO-derived, non-infectious Retrovirus Like Particles (RVLP) that serve as a BSL-1 compatible spiking agent for viral clearance testing. 

Key Learning Objectives:

  • Learn how viral clearance prediction is possible using non-infectious mock virus particles that mimic the physicochemical properties of live mammalian viruses.
  • Understand how this approach can be applied to downstream efforts such as design of experiments, process optimization and “Prior Knowledge” utilization.
  • Review several case studies utilizing MockV® RVLP particles in a BSL-1 lab setting.

Who Should Attend:

  • Bioprocess scientists (Downstream/Purification)
  • Bioprocess engineers (Downstream/Purification)
  • Bioanalytical scientists (Assay Development scientists)
  • Directors, Purification Sciences
  • Viral Clearance/Viral Safety Scientists


David Cetlin
Sr Director, MockV® Products
Cygnus Technologies

David Cetlin is the Senior Director of MockV® Products at Cygnus Technologies, LLC. Mr. David founded MockV® Solution in 2013 and was CEO until its acquisition by Cygnus in 2020. His lab is dedicated towards establishing a series of BSL-1 compatible viral clearance prediction kits. These kits aim to benefit downstream purification scientists as they develop, characterize and validate their downstream purification processes.

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