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1.1 INTRODUCTION

Much has already been written about process validation for biopharmaceuticals, and there are worldwide guidelines already established. Why, then, did we decide to produce yet another book on this topic? For starters, the guidelines addressing validation are usually purposefully broad to allow for the variability in products, manufacturing methods, analysis, clinical indications, patient populations, and doses for

biopharmaceuticals. As a result, there is still much discussion related to validation approaches and specific issues that must be addressed to satisfy regulatory authorities and reproducibly produce safe and efficacious biopharmaceuticals. Furthermore, developing technologies, both analytical and manufacturing, can impact validation, and it is expected that sponsors of biopharmaceuticals will remain current with new developments.