Amino acid modifications
Analysis of Amino Acid Modifications
Building on the analysis of the primary structure, one of the most important tasks is to identify and quantify post-translational amino acid modifications. These modifications, which occur ubiquitously in natural as well as recombinantly produced proteins, can have a fundamental influence on the functionality of the protein, making their characterization subject of particularly sensitive and accurate analysis.
Our highly experienced scientists at Biofidus know how to routinely and reliably distinguish non-critical modifications from those that could have a significant impact on the functionality of your biologic or biosimilar.
Our deep knowledge in this field allows us to guide you through the variety of available state-of-the-art methods like LC-MS based multiple attribute methods (MAM) and helps 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 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
- Glycosylation
- Oxidation
- Acetylation
- Amidation
- Deamidation
- Phosphorylation
- Iso-Aspartate, Pyroglutamate
- PEGylation, …
- Drug-to-antibody ratio (DAR) for ADCs
- Molecular weight determination
- Peptide Mapping
- Multi attribute methods (MAM)
Tell us about your project
We‘ll advice you to define your assay needs
Technologies used
- LC-ESI-TOF
- MALDI-TOF
- Multi attribute methods (MAM)
Please reach out to Our CEO Dr. Benjamin Müller for all requests regarding amino acid modifications.
Phone: +49 (0)521 329 363 41
Mail: Benjamin.Mueller@Biofidus.com