Introduction to Biopharmaceutical Analysis

During development, full characterization of a biopharmaceutical is required. Due to their size, complexity, and heterogeneity, analysis is typically more complex in comparison to the analysis of small molecules. Therefore, a range of liquid chromatographic techniques alongside mass spectrometric detection are combined and utilized. Among biopharmaceuticals monoclonal antibodies (mAbs) are the most promising class of therapeutic molecules, therefore, we will focus on the analysis of these types of molecules using IEX, SEC, RPLC, and HILIC. This module will provide an overview of the different techniques used in biopharmaceutical analysis.

Topics include:

• Biopharmaceutical analysis overview
• Introduction and benefits (reversed phase HPLC)
• Reversed phase mechanism of interaction
• Protein level analysis by reversed phase HPLC
• Peptide level analysis by reversed phase HPLC
• Amino acid level analysis by reversed phase HPLC
• Hydrophilic interaction liquid chromatography (HILIC)
• Size exclusion chromatography (SEC)
• Ion exchange chromatography (IEX)