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. Such as N-terminally blocked proteins, where traditional N-terminal Edman sequencing does not work. Also, with MALDI-ISD truncated isoforms and post translationally modified terminals can be identified.
Do you follow the ICH Q6B? (Test Procedures and Acceptance Criteria for Biotechnological or Biological Products). Then the ICH Q6B requires that you provide an overview of the N- and C-term amino acid sequence of your drug substance. Our experts provide you with a report to use in your project to live up to the requirements.
Our service includes:
- N- and C-terminal sequence of your sample analysis by MALDI-ISD.
- Determination of 20-80 amino acids from each terminal of the protein.
- Comparison with the expected drug substance sequence.
- MALDI-MS intact protein Mw determination.
Below you will find our simple order form. Or you can send us a request so we can discuss the analyses for your specific needs.
Download application note (pdf – 766 kb)