Fundamentals Of Viral Clearance Studies Part 5: How Much Is Enough?
By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance
A common concern for manufacturers of biopharmaceutical products is whether their process achieves sufficient viral clearance. There is no fixed level of viral reduction that all manufacturing processes for biopharmaceutical products must achieve. Each biopharmaceutical product uses unique source materials and a unique manufacturing process, and so each product has its own unique risk for potential viral transmission. Therefore the level of viral reduction required to achieve an acceptable viral safety risk is specific to each product.