Our scientists are highly experienced providers of biopharmaceutical protein characterization services, simply because we have been developing our skills in this industry for a long time.
We have been working closely with Bruker, a leading manufacturer of contemporary mass spectrometer hardware, since their emergence on the market in the mid 1990s. This puts us in the enviable position of having had time to build our competencies to a very robust level.
Our major strengths when it comes to protein characterization are:
As proteins are complex molecular entities derived from biological processes, they are almost always not fully purified and homogeneous molecules, but instead show a certain degree of structural heterogeneity. This means that the characterization of a protein always has three aspects:
Furthermore, analysis of a protein is not complete without characterizing its functional integrity.
We provide you with the full range of services, from drug discovery and development, to release testing and regulatory compliance under ICH Q6B.
You can choose from the following services.
Protein quantification by amino acid analysis and extinction coefficient. These methods allow high precision and accuracy for what is usually quite a difficult task.
Protein primary structure analysis, which involves a combination of different techniques (i.e. peptide mapping, de-novo sequencing, intact mass, N/C-terminal sequencing and disulfide linkage) to allow for a complete understanding.
Glycosylation analysis, to identify common and biologically relevant modifications. Several techniques (i.e. N-linked glycosylation, O-linked glycosylation, sialic acid, site of modification, quantification, monosaccharide) can be applied.
Bioassays, which are integral to quality assessment during the development and manufacturing of biological drugs. We can set up GMP-compliant assays for a wide range of ligand binding assays (ELISA) and cell-based assays, all of which are highly robust and reliable.
Impurities analysis, to assist with the purification of proteins and enable you to use them in research or medical applications. We can undertake testing for both process-related impurities and product-related impurities.
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Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |