Viral Clearance Strategies for Continuous Chromatography Processes

WEBINAR

Chromatography is regularly investigated in clearance studies to assess the capacity to remove viruses. Historically columns were run in batch mode, and the virus validation studies have been designed accordingly. However, many manufacturers are now implementing continuous chromatography to take advantage of the efficiencies and cost savings that this provides. In response, clearance studies have to be modified to take into account the multi-column process and the impact that this has on sample composition, etc.

In this webinar, our experts will discuss new regulatory guidance for continuous chromatography and review case studies where different study designs have been used to investigate virus removal.

In this webinar, you will:

• Get an introduction to the recommendations from ICH Q5A (R2) and other guidelines about the viral safety of continuous chromatography processes.
• Understand the critical parameters that need to be considered when designing a virus clearance study for a continuous chromatography process.
• Get a review of different virus clearance study designs that can be adopted and the advantages and disadvantages of each.