High Resolution Size Exclusion Chromatography (SEC) Analysis of Intact Protein Biotherapeutics

High molecular weight (HMW) aggregates and low molecular weight (LMW) fragments of biotherapeutic proteins induced by various stress conditions can be formed during the process of drug development, storage, shipment, or delivery. These size variants are critical quality attributes (CQAs) that need to be well characterized.

Size exclusion chromatography (SEC) HPLC is a commonly used technique to characterize and quantify size variants of these biotherapeutic proteins. The United States Pharmacopeia monograph method also recommends SEC for determining purity and aggregates of protein therapeutics.

Presenter: Suresh Babu C.V. (Solution Development Scientist, Agilent Technologies)

Dr. Suresh Babu C.V. completed his PhD in Biomolecular Science from University of Science and Technology (Korea Institute of science and Technology), South Korea and did his Postdoctoral fellow at School of Medicine, University of Cincinnati, USA. He has presented various papers in international and national conferences, and has published more than 25 papers in reputed peer reviewed journals. He has an extensive experience in biopharmaceutical characterization, method development, validation and in interpretation of chromatogram, electropherogram and mass spectral data for biomolecule analysis. Currently he is working as Solution Development Scientist at Agilent Technologies for past 10 years focusing on biopharmaceutical characterization. His areas of interest in Biopharma include- LC, LC/MS, CE, CE-MS, electrophoresis, and mass spectrometry.

Presenter: Ansuman Mahato (Application Specialist LC, Agilent Technologies)

Mr. Ansuman Mahato received his Master’s degree from Bangalore University in Biotechnology. He has been working in Agilent as senior application specialist for liquid chromatography in Center of Excellence lab. He carries rich experience on liquid chromatography platforms like GPC/SEC, HPLC, UHPLC, regulatory method transfers, life cycle management of analytical methods, and drive industry collaboration for new solution development. He has been developing applications for various market segments like Pharma, Food, chemical & energy and biotherapeutics workflows.

Presenter: Ms. Paramjeet Khandpur (Product Specialist, Agilent Techologies, India)

Ms. Paramjeet Khandpur, M.Tech. received Bachelor’ degree in Chemical Engineering from VTU University and Master’s under Dr. Parag Gogte in Bioprocess Technology from the Institute of Chemical technology, Mumbai. During her research tenure, she has published 6 research articles in several international journals. Paramjeet is working as Application Scientist in Centre of Excellence Laboratory, Bangalore, Agilent Technologies India Pvt. Ltd. At Agilent, she has been working on liquid chromatography platforms like HPLC, UHPLC, 2D LC and preparative LC solutions. She is working in collaboration with several users in the Pharma/Biopharma industry for method development activities, HPLC to UHPLC method transfer, troubleshooting method related issues and has experience on various workflow of Pharma & Bio-Pharma markets. Prior to joining Agilent, she worked as a faculty at Biotechnology Department, VTU university, Karnataka.