Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions

By Taylor-Anne Gorman, Dr Sophie Moncrieff, Dr Graeme Anderson, Sartorius-Stedim BioOutsource

During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. At Sartorius Stedim BioOutsource, we are developing and have developed a number of SPR assays which use Biacore instruments to assess binding of drug molecules to target molecules, FcRn, and Fcγ-Receptors, and are able to provide an overview of the performance of a biosimilar molecule.

Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand. Sensorgram comparison was then used to give an additional level of comparability to the original data, resulting in a better understanding of the correlation between functional and physiochemical results. This white paper summarises the information from a talk given by Dr Graeme Anderson, at DIPIA in 2018.