INTRODUCTION

This chapter describes virology test methods applicable to the development of biological product drugs, such as recombinant proteins, subunit vaccines, therapeutic monoclonal antibodies, and growth hormones. Several topics are excluded from the scope of this chapter:

• Blood- and plasma-derived products as well as whole blood and plasma products used directly in transplantation or infusion. However, the basic principles, strategies, and testing methods for ensuring virus-free products are applicable.

• Methodologies for the safety testing of live viral vaccines.

• Specific methods for viral clearance studies, which are described in the USP general information chapter Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 〈1050〉.