Liquid Chromatography in BioPharma

Instructor: Jennifer Lewis, PhD, University of Rhode Island

Location: URI   
Session 1: June 24-26 ( Location TBD)

Course Overview

This 2.5-day RI-INBRE Workforce Development Training (WDT) Module introduces how liquid chromatography is used in BioPharma. The first section of this module focuses on teaching students the basic principles of chromatography, why it is
so important to the BioPharma industry, and how it is applied to protein-based drug products (e.g., Humira, Enbrel, Neulasta). The second section focuses on working in current Good Manufacturing Practice (cGMP) biomanufacturing environments performing release and stability testing of biological drug products. The module includes a hands-on laboratory experiences giving students an opportunity to analyze a mock product using high performance liquid chromatography (HPLC). Upon completion, participants will receive an RI-INBRE Certificate of Completion.

Learning Outcomes

This module teaches students the essentials of chromatography for biopharmaceuticals with a focus on monoclonal antibody therapeutics. Upon completion, students will have a fundamental understanding of chemistry of separation of large molecules for purposes of GMP manufacturing and GMP analytical testing. The primary aim of this course is to lay the groundwork for students’ future studies in pharmaceutical sciences.

Lab Report

Students will be expected to maintain detailed laboratory notes

Resources Used in this Module:

  • Standard Operating Procedure – Waters Alliance™ HPLC System

Proposed Timeline (subject to change)

Day 1Day 2Day 3
9:00 AM-10:00 AMChromatography I (lecture)Quality, Compliance and GMP in Biopharmaceutical Industry (lecture)Conclusion and Result Discussion
(Open Discussion)
10:00 AM-11:00 AMProtein Chemistry 101 (lecture)Protein Chromatography (lecture)Conclusion and Result Discussion
(Open Discussion)
11:00 AM-12:00 PMColumn Packing Exercise (lab)Release and Stability Testing of Biopharmaceuticals (lecture)Conclusion and Result Discussion
(Open Discussion)
12:00 - 1:00 PMBreakBreakWDT Survey and
Certificate Distribution
1:00 PM-2:00 PMChromatography II (lecture)Quality, Compliance and GMP in Biopharmaceutical Industry (lecture)
2:00 PM-3:00 PMIntroduction: Biopharmaceutical manufacturing (lecture)Size Exclusion Chromatography (SEC) Exercise (lab)
3:00 PM-4:00 PMProtein Purification, Downstream Processing (lecture)Size Exclusion Chromatography (SEC) Exercise (lab)