We hope that you have been enjoying Dr. Kathryn Remington’s viral clearance series as featured in Bioresearch Online.
In Part 5: How Much is Enough, the final article of the series, Kathryn provides insight into what level of viral reduction is required to achieve an acceptable viral safety risk and how that can vary for each product. In addition, she speaks to the approach regulatory agencies take to the level of viral reduction based on the potential viral load of the starting materials.
Here is a look back at the first 4 parts of the series:
- Part 1: Fundamentals Of Viral Clearance Studies Part 1: Selection Of A Viral Panel And An Appropriate Virus Spike
- Part 2: How To Design Pre-Study Experiments For Viral Clearance Studies
- Part 3: Fundamentals Of Viral Clearance Studies Part 3: Study Design Factors For Optimal Log Reduction
- Part 4: Fundamentals Of Viral Clearance Studies Part 4: Considerations For Evaluating Viral Clearance By Chromatography Steps
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