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Course Details
In this webcast, we’ll explore the essential chromatographic analyses used to ensure the quality and consistency of proteins produced through biotechnology. We’ll cover critical topics like ICH quality attributes, impurity definitions, and a range of complementary chromatographic analyses required to give an accurate assessment of a protein.
Topics include:
- Outline of ICH critical quality attributes
- Aggregation and charge variance analysis
- Protein subunit heterogeneity
- Process and product impurity profiling
- Peptide mapping
- Drug-antibody ratio in ADCs
- Amino acid composition
- Glycoprofiling
