BioPharmaSpec scientists designed the first successful strategies for protein sequencing and have remained at the forefront of this technique for the last three decades. We use our expert knowledge of the methodologies and instrumentation application to provide our clients with quality sequence data that they can rely on.
Regulatory authorities are increasingly requesting confirmation of primary amino acid sequence at the protein level. This is essential for the development of a biosimilar, where you must ensure that the primary protein sequence is identical to that of the innovator product.
In order to determine the primary amino acid sequence of your biopharmaceutical, BioPharmaSpec perform the following analyses:
1. On-line LC/ES-MS/MS and/or MALDI-TOF/TOF analysis, as appropriate, and analysis of the peptides obtained from multiple digests of the product.
2. As MS-based sequencing may not distinguish the isobaric amino acids Ile and Leu, peptides containing these amino acids will be purified and further subjected to Automated Edman Degradation (N-terminal sequencing) in order to identify the Ile/Leu positions unambiguously.