Anurag S. Rathore

A novel mathematical approach for fitting concentration-response curves is proposed that offers a more accurate estimation of potency data.

This article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

The authors review some of the monoclonal antibody candidates that reached Phase III clinical trials but were discontinued at later stages.

The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.

The need for real-time monitoring and control has spurred the development of new analytical tools.

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.