Anurag S. Rathore

Amid the rush for a SARS-CoV-2 vaccine to deal with the COVID-19 pandemic, a robust risk assessment must be conducted, and mitigation strategies applied.

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.

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.

The authors review how media components modulate the quality of monoclonal antibody products

Chromatography modeling can enhance bioprocessing efficiencies.