INTRODUCTION AND SCOPE

Administration of natural source or recombinant biologic medicines may elicit some degree of immune response leading to development of anti-drug antibodies (ADAs) in treated subjects. Neutralizing antibodies (NAbs) are a subset of ADAs that affect the biological activity of the biologic drug product. For the purposes of this chapter, NAbs are defined by their ability to neutralize the biological activity of a therapeutic in an in vitro system. This chapter does not address antibodies that may impact drug clearance. Further clinical studies would be needed to assess changes in biologic activity on therapeutic outcomes.