PROTEIN SEQUENCing
Protein sequencing
Although the general structure of proteins is encoded by the sequence of its amino acids, the full characterization of the structure and associated biological functionality is not completed with the determination of the simple sum of amino acids but is subject to a series of very complex analyses.
For any protein-based drug, characterization of the theoretically expected primary structure is of paramount importance and should always be the first pillar of a detailed structural analysis of your biologic or biosimilar.
Our comprehensive analytical portfolio includes a variety of state-of-the-art bioanalytical services to identify the exact amino acid sequence, N- and C-terminal modifications, molecular weight as well as the identification of potential mutations.
Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, its individual formulation matrix and your distinct analytical question.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
Our capabilities
- Sourcing of reference products (Originators)
- Amino acid sequence verification by LC-MS
- Characterization of post translational modifications (PTMs)
- Characterization of reference product and establishment of quality target profile
- Method qualification according to ICH guidelines
- Comparability studies
- Stability studies
- Accelerated stability studies
- Forced degradation studies
- Batch testing
bioanalytical services
- Amino acid sequence, N-& C-terminal truncation
- Amino acid content after protein hydrolysis by LC-FLD incl. determination of extinction coefficient
- N-and C-terminal sequencing by MALDI-TOF / LC-ESI-TOF
- N-terminal sequencing by Edman (partner laboratory)
- Peptide mapping by LC-ESI-TOF
- Peptide mapping by RP-UV
- Molecular weight determination by MALDI-TOF
- Molecular weight determination by LC-ESI-TOF
- mABlysine clipping by CEX-UV
Tell us about your project
We‘ll advice you to define your assay needs
Technologies used
- LC-FLD
- LC-ESI-TOF
- MALDI-TOF
- Edman
- RP-UV
- CEX-UV
Please reach out to Our CEO Dr. Benjamin Müller for all requests regarding primary structure characterizations of proteins.
Phone: +49 (0)521 329 363 41
Mail: Benjamin.Mueller@Biofidus.com