Biophysical Analysis of Therapeutic Antibodies in the Early Development Pipeline.

Abstract

The successful progression of therapeutic antibodies and other biologics from the laboratory to the clinic depends on their possession of "drug-like" biophysical properties. The techniques and the resultant biophysical and biochemical parameters used to characterize their ease of manufacture can be broadly defined as developability. Focusing on antibodies, this review firstly discusses established and emerging biophysical techniques used to probe the early-stage developability of biologics, aimed towards those new to the field. Secondly, we describe the inter-relationships and redundancies amongst developability assays and how in silico methods aid the efficient deployment of developability to bring a new generation of cost-effective therapeutic proteins from bench to bedside more quickly and sustainably.