![]() Selection of analytical methods and acceptance criteria that will be applied to demonstrate comparability can be the most difficult step in a comparability exercise. Any doubt about data from such studies could translate into unforeseen pharmacological or nonclinical studies - or worse, clinical studies. According to ICH Q5E, a comparability exercise should provide analytical evidence that a product has highly similar quality attributes before and after manufacturing process changes, with no adverse impact on safety or efficacy, including immunogenicity ( 1). ![]() Comparability has become a routine exercise throughout the life cycle of biotechnological products.
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