Biophysical Analysis of Therapeutic Antibodies in the Early Development Pipeline

Leon F Willis,1 Nikil Kapur,2 Sheena E Radford,1 David J Brockwell1 1School of Molecular and Cellular Biology, Astbury Centre for Structural Molecular Biology, Faculty of Biological Sciences, University of Leeds, Leeds, LS2 9JT, UK; 2School of Mechanical Engineering, Faculty of Engineering and Physical Sciences, University of Leeds, Leeds, LS2 9JT, UKCorrespondence: David J Brockwell, Email [email protected]: 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.Keywords: developability, biophysics, protein, antibody, analytical techniques