Want to know the N-terminal amino acid sequence of your drug substance protein?
We can list up to 40 amino acids of your drug substance. To do this, we use N-terminal Edman degradation. Our experts perform N-terminal sequencing, using the newest technology.
Edman degradation is a cyclic procedure. We cleave off the amino acid residues one at a time. Then we identify them by chromatography. If the sample holds 2-3 sequence variants the degradation can show this. However, if the sample contains multiple N-terminals it is not possible to read the aa sequence.
Following ICH Q6B? (Test Procedures and Acceptance Criteria for Biotechnological/Biological Products). ICH Q6B requires N-terminal sequencing of a drug substance.
Our N-terminal sequencing service includes:
- Optional 1D SDS PAGE or HPLC isolation of the protein.
- Sequencing by Edman degradation.
- Determination of up to 40 amino acids.
- Finally, a comparison to expected drug substance sequence.
We deliver the data in a report, which is easy to understand and use in your studies.
Download application note (pdf – 1 MB)
Not exactly what you are looking for? Then send us a request for a customized project proposal to meet your specific needs.
Need a faster and less expensive analysis? Take a look at our PICK ‘n POST Edman sequencing service. With this service you get the first 5, 10 or 20 amino acids analyzed in just 4-8 days!