terminal sequence

Creative Biolabs have established a platform to analyze amino acid sequence of therapeutic drug candidates, strictly following the ICH Topic Q6b guideline. The amino acid sequence of the desired product should be evaluated utilizing approaches such as amino acid composition, terminal amino acid sequence, peptide map, sulfhydryl group(s) and disulphide bridge analysis and then compared with the amino acid sequence deduced from the gene sequence of the desired product. Terminal amino acids should be analyzed to determine the nature and homogeneity of the amino (N-) and Carboxy (C-) terminal amino acids. When the desired product is found to be heterogeneous with the respect on amino acids, the relative proportion of variant forms should be identified using an appropriate analytical procedure. The terminal amino acids should also be compared with the ones deduced from the gene sequence of the desired protein.