Peptide mapping, the principal technique for confirming a protein’s primary structure (amino acid sequence), can be used in drug discovery and throughout the manufacturing process. It is one of the most important techniques in comparability studies of biologics and a key step in the characterization of biopharmaceutical proteins. For recombinant protein drugs, such as monoclonal antibodies (mAbs) and antibody drug conjugates (ADCs), peptide mapping can be used for identification, primary structural characterization, and quality assurance/quality control (QA/QC). Some global regulators, like the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA), have developed guidelines to ask for providing peptide mapping to confirm the amino acid sequence of drug substance proteins.
Peptide Mapping Service at Creative Proteomics
At Creative Proteomics, we have developed a liquid chromatography with tandem mass spectrometry (LC-MS/MS)-based peptide mapping platform for confirmation of protein primary structure. And we can provide the peptide mapping service to analyze the sequence of biopharmaceuticals and confirm complete expression of recombinant protein in compliance with ICH Q6B.
Figure 1. Workflow of Peptide Mapping Service at Creative Proteomics
As peptide mapping service compares the peptide masses with protein databases, only proteins from the database can be identified using this method. Proteins, whose sequence is not found in a protein database, such as antibodies or novel proteins, can be deduced by our service of de-novo sequencing. In addition, we can provide detailed reports, including:
Points of Interest in Peptide Mapping Services
Our peptide mapping service can help clients to comply with ICH Q6B guidelines in support of marketing applications. At Creative Proteomics, peptide mapping services have different uses, including but not limited:
With professional and experienced staff, Creative Proteomics provides high-quality peptide mapping services. Our peptide mapping service is not only for structural characterization and confirmation, but provides a whole suite of information to help inform the drug development process. Our ordering procedure is as follows. As every project has different requirements, please contact our specialists to discuss your specific needs.