Do you want to confirm the N- and C terminal sequence of your drug substance protein?
By using MALDI-ISD we can determine up to 80 amino acids from the N-terminal of your drug substance protein. Also, we map up to 80 amino acids from the C-terminal. N- and C-terminal sequencing by MALDI-ISD works for terminally modified proteins. These include N-terminally blocked proteins, where traditional N-terminal Edman sequencing does not work. In addition, MALDI-ISD identifies truncated isoforms and post translationally modified terminals.
Do you follow the ICH Q6B? (Test Procedures and Acceptance Criteria for Biotechnological or Biological Products). Then the ICH Q6B requires that you prepare an overview of the N- and C-terminal amino acid sequence of your drug substance. Rely upon our skilled experts to provide you with a report to live up to the requirements for your projects.
Our service includes:
- First an N- and C-terminal sequencing of your sample analysis by MALDI-ISD.
- Determination of 20-80 amino acids from each terminal of the protein.
- Then a comparison with the expected drug substance sequence.
- Finally, MALDI-MS intact protein Mw determination.
Use the simple order procedure below or send us a request. We will happily make an assessment on how to meet your specific analysis needs.
Download application note (pdf – 766 kb)