Current Methods and Approaches for Viral Clearance

Tim Sandle has written a discussion article for American Pharmaceutical Review on the subject of viral clearance. The abstract reads:

“Complete viral safety, as defined by absolute freedom from extraneous viral agents, is not easy to achieve and some would argue that it is an impossible task due to the difficulties in testing for the full range of pathogenic viruses and residual pathogenicity. The process is also complicated by viral inactivation being rarely linear. It can also be that viruses are subsequently discovered several years after a batch has been manufactured. Therefore, whilst product testing can support control measures in terms of the showing that the probability of viral contamination is low, greater confidence is garnered through viral clearance strategies and associated risk assessment.

This article assesses the key factors for viral clearance and considers the current methods used to remove viral particles from the product stream.”

The reference is:

Sandle, T. (2015) Current Methods and Approaches for Viral Clearance, American Pharmaceutical Review, September / October 2015: 1-4

For a copy, please contact Tim Sandle

Posted by Tim Sandle