Regulatory Advice

| 01 October 2009

Before you decide how many inactivation/removal steps you require, it is vital to understand the nature of your product and the manufacturing processes required. Even if a manufacturing process includes two to three virus inactivation/removal steps, it can still fail to meet the most stringent regulatory reviews. From a regulator's point of view, sufficient viral clearance in a manufacturing process depends upon the various strategies, methods and technologies employed. For example, a product that completely excludes components of animal origin is likely to require less virus clearance to satisfy a health authority than a product that uses such components. Moreover, the nature of the animal-derived components and potential virus contaminants also need to be considered. For a product with animal-derived components, it might be useful to obtain expert advice regarding likely or potential viral contamination.


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