Ranking mAb-excipient interactions in biologics formulations by NMR spectroscopy and computational approaches.

ABSTRACT: Excipients are added to biopharmaceutical formulations to enhance protein stability and enable the development of robust formulations with acceptable physicochemical properties, but the mechanism by which they confer stability is not fully understood. Here, we aimed to elucidate the mechanism through direct experimental evidence of the binding affinity of an excipient to a monoclonal antibody (mAb), using saturation transfer difference (STD) nuclear magnetic resonance (NMR) spectroscopic method. We ranked a series of excipients with respect to their dissociation constant (K_D) and nonspecific binding constants (N_s). In parallel, molecular dynamic and site identification by ligand competitive saturation (SILCS)-Monte Carlo simulations were done to rank the excipient pro

SUBMITTER: Zhang C 

PROVIDER: S-EPMC10208151 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature