Chapter 5: Lessons Learned in Understanding Dual Variable Domain-Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates

Abstract

The successful delivery of any novel biotherapeutic to patients requires the translation of discovery concepts to clinical enablement. Based on our experience in the development of mAb therapeutics and in evaluating 1000s of DVD-Ig molecules, in this chapter we will briefly discuss (i) critical aspects considered in developing the DVD-Ig platform and (ii) the lessons learned in selecting therapeutic grade DVD-Ig molecules, specifically with regard to how various structural components impact (a) structural-functional properties, (b) biophysical and biochemical properties, (c) PK profiles, and (d) manufacturability (i.e., expression, formulation, etc.).