Structural Characterization and Confirmation
Structural Characterization and Confirmation
Due to the biosynthetic processes used to produce biopharmaceuticals, an inherent degree of structural heterogeneity is often present in finished product, meaning the finished product can be a mixture of post-translationally modified forms
Full structural characterization is often required for these products and Almac have a number of tools at their disposal for this:
- High resolution mass spec protein mapping
- Amino acid analysis according to USP 1052
- N- and C- terminal sequence analysis
- De novo sequencing
- Sulfhydryl group and disulfide bond analysis
- Carbohydrate structure analysis
Downloadable summaries are hyperlinked explaining these analytical technologies in more detail.