Host Cell Protein Analysis in Biologics Manufacturing

Explore how advances in analytical technologies are reshaping how manufacturers understand and manage impurity profiles.

Article

Published: June 30, 2025

Neeta Ratanghayra, MPharm

speaking with

Jared R. Auclair, PhD

& Anurag S. Rathore, PhD

Rows of pharmaceutical vials on a production line, relevant to host cell protein analysis in biologics.

Credit: iStock

Biologics manufacturing demands precision, and one of the greatest challenges is controlling host cell protein (HCP) impurities. Even in trace amounts, these proteins can compromise drug stability, trigger immune responses and impact patient safety. As a result, their detection, quantification and risk assessment are under growing regulatory scrutiny.

This article explores how evolving analytical techniques are improving HCP analysis. Experts discuss the limitations of traditional ELISA methods, the growing role of mass spectrometry and why a multi-method approach is becoming essential.

Read on to learn how manufacturers are redefining best practices to deliver safer, more consistent biologics.

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Meet the Author

Neeta Ratanghayra, MPharm

Freelance Medical Writer

Neeta Ratanghayra is a freelance medical writer specializing in developing content for the pharma, biotech and healthcare industries. She has a Master’s degree in Pharmacy and has worked on a variety of medical writing deliverables for global pharma companies and healthcare organizations. Before delving into medical writing, Neeta worked in the clinical research industry, where she handled multiple clinical research projects intended for various regulatory submissions.

Interviewing

White letters "JA" on a navy background.

Jared R. Auclair, PhD

Dean of the College of Professional Studies and Director of Bioinnovation

Jared R. Auclair, PhD, is currently the dean of the College of Professional Studies and director of bioinnovation at Northeastern University. Dr. Auclair directs the Biopharmaceutical Analysis Training Laboratory and oversees the Asia-Pacific Economic Cooperation Center of Regulatory Excellence in Biotherapeutics. His research expertise includes analytical chemistry, protein biochemistry and regulatory science with a focus on biopharmaceutical development and analysis. He holds a bachelor’s degree in biotechnology from Worcester Polytechnic Institute and a PhD in biomedical science from the University of Massachusetts Medical.

White letters "AR" on a navy background.

Anurag S. Rathore, PhD

Professor and Head of the Department of Chemical Engineering

Anurag S. Rathore, PhD, is a professor and head of the Department of Chemical Engineering at IIT Delhi. He also serves as Coordinator of the DBT Center of Excellence for Biopharmaceutical Technology. At IIT Delhi, Dr. Rathore leads the Bioprocessing and Bioseparations Laboratory. His research aims to develop robust and economical processes for the manufacturing of safe and efficacious drugs. A Yale PhD and former industry leader, Dr. Rathore has authored over 700 publications and is widely recognized for his contributions to biopharmaceutical innovation.

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