Biopharmaceutical Product Characterization Techniques
Analytical methods used for testing biotherapeutics will be examined. Emphasis is placed on assessing protein concentration, purity, identity and activity. The importance of sample processing, throughput and level of validation will be explored as samples from upstream processing, downstream processing and final bulk are interrogated. Students will also learn key concepts used to validate the performance of analytical methods. This is a half-semester, lab-based course.
- MALDI-TOF mass spectrometry
- Spectroscopy (absorbance and fluorescence)
- Electrophoresis – Qualitative (SDS-PAGE) vs. quantitative (CE) analysis; assessing purity
- HPLC: reverse phase, size-exclusion, and cation exchange
- Protein stability testing