The Application of Chromatography in the Biopharmaceutical Industry:
Powerful Separation and Analysis Tool
Instructor: Jennifer Lewis, PhD, University of Rhode Island
Location: URI
Session 1: July 22 – July 24 ( Lab: PDI Lab 310 / Lecture Room: Avedisian Rm 403)
Course Overview
This WDT Module offers an introduction to modern chromatography techniques that are widely used in Biopharmaceutical Industry; chromatography of large drug molecules vs. small, synthetic drug molecules. The first section of this module focuses on basic principles of chromatography, why it is so important to industry, and how it is applied to protein-based drug products (e.g., Humira, Enbrel, Neulasta). The second section dives into the application of chromatography in Good Manufacturing Practice (GMP) environments for bioprocess and release and stability testing of drug products with hands-on laboratory experiences. The module will be completed over 2.5 days and participants who complete the module will receive an RI-INBRE Certificate of completion.
Learning Outcomes
- Participants learn essentials of chromatography for biopharmaceuticals with a focus on monoclonal antibody therapeutics
- Possess a fundamental understanding of chemistry of separation of large molecules for purposes of GMP manufacturing and GMP analytical testing
- 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
Timeline
| 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) |