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 characterization 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 characterization analysis should be conducted, and the relativeView Resource
Almac API, Chemical Development, Analytical & Solid State Services
Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).
We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.
Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.