Viral Clearance
There is a difference between virus inactivation
and virus removal. Virus inactivation results in the irreversible loss
of infectivity, while virus removal means the reduction of infective virus
particles in number. The validation of viral clearance is very well described
in regulatory guidelines, which also provides very clear recommendations
on the choice of model viruses and the appropriate statistical approach
for the calculation of the clearance factor.
| Viral Clearance and
Validation
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©1999 Charm Bioengineering, Inc.