Case study

N- and C-terminal sequence analysis

N- and C-terminal sequences play an important role in the structure of proteins and polypeptides and can influence their biological function. The N-terminal and C-terminal sequences of biopharmaceuticals are important characteristics for licensing applications and form a key part of the ICH Q6B Guidelines for biotechnological/biological products. The analysis is also necessary to demonstrate comparability and consistency between cGMP batches.

Therefore, structural characterisation of a biopharmaceutical product should include assessment of the N- and C-terminal sequence. This analysis provides confirmation of the consistency and homogeneity between batches for lot release purposes and can reveal if proteins have been truncated or N-terminally blocked. If heterogeneity with respect to terminal amino acid sequences is found, further characterisation analysis should be conducted, and the relative

View Resource

Download here instantly

This website uses cookies. By continuing to browse the site, you are agreeing to our use of cookies