Anurag S. Rathore

Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.

A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules.