Liquid Chromatography in BioPharma
Instructor: Instructors: Jennifer Lewis, PhD, and Erin Bastien, MS, Pharmaceutical Development Institute, University Rhode Island
Location: CR XXX, Lab 310
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 1 | Day 2 | Day 3 | |
|---|---|---|---|
| 9:00 AM-10:00 AM | Chromatography I (lecture) | Quality, Compliance and GMP in Biopharmaceutical Industry (lecture) | Conclusion and Result Discussion (Open Discussion) |
| 10:00 AM-11:00 AM | Protein Chemistry 101 (lecture) | Protein Chromatography (lecture) | Conclusion and Result Discussion (Open Discussion) |
| 11:00 AM-12:00 PM | Column Packing Exercise (lab) | Release and Stability Testing of Biopharmaceuticals (lecture) | Conclusion and Result Discussion (Open Discussion) |
| 12:00 - 1:00 PM | Break | Break | WDT Survey and Certificate Distribution |
| 1:00 PM-2:00 PM | Chromatography II (lecture) | Quality, Compliance and GMP in Biopharmaceutical Industry (lecture) | |
| 2:00 PM-3:00 PM | Introduction: Biopharmaceutical manufacturing (lecture) | Size Exclusion Chromatography (SEC) Exercise (lab) | |
| 3:00 PM-4:00 PM | Protein Purification, Downstream Processing (lecture) | Size Exclusion Chromatography (SEC) Exercise (lab) |