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Exploring Biopharmaceutical Analysis with Compact Capillary Liquid Chromatography Instrumentation.
Benjamin P Libert1, Samuel W Foster1, Elisabeth P Gates2
1Rowan University.
LC GC Europe
|July 24, 2023
Summary
Miniaturized liquid chromatography (LC) systems offer portable analysis for pharmaceutical manufacturing. A portable LC instrument coupled with mass spectrometry (MS) was used for monoclonal antibody (mAb) characterization.
Area of Science:
- Analytical Chemistry
- Biopharmaceutical Analysis
- Process Analytical Technology (PAT)
Background:
- Miniaturization of analytical instrumentation is a growing trend.
- Portable liquid chromatography (LC) systems enable on-site analysis, reducing sample transport.
- In-situ monitoring is crucial for pharmaceutical and biopharmaceutical manufacturing.
Purpose of the Study:
- To describe a portable, miniaturized LC instrument.
- To demonstrate its application in characterizing a biopharmaceutical monoclonal antibody (mAb).
- To highlight the utility of portable LC-MS in manufacturing environments.
Main Methods:
- Development and implementation of a portable, miniaturized LC system.
- Coupling of the LC system to a mass spectrometer (MS).
- Application of the LC-MS system for the characterization of a monoclonal antibody (mAb).
Main Results:
- Successful characterization of a biopharmaceutical monoclonal antibody (mAb) using the portable LC-MS system.
- Demonstration of the feasibility of on-site analysis in a manufacturing setting.
- Validation of miniaturized LC technology for biopharmaceutical quality control.
Conclusions:
- Portable, miniaturized LC-MS instruments are suitable for biopharmaceutical characterization.
- These systems enhance flexibility and enable real-time process monitoring.
- The technology supports efficient quality control directly within manufacturing environments.
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