For developing Biopharmaceuticals such as Biosimilars or new biological entities (NBEs) we support customer approaches by all-in-one-hand service with including full analytical support, complete documentation and outstanding project management to gain market success.
We offer analytical support from research to approval regarding:
- Clone Selection & Process Development
- Extended Charaterization & Comparability
- Stability & Release
As proteins are complex molecular entities derived from biological processes, they show a certain degree of structural heterogeneity. This means that the characterization of a protein always has four aspects:
- Identifying the major protein component
- Identifying the minor components
- Quantifying the minor components (both process- and product-related impurities)
- Characterizing the functional integrity
We provide our customers with the full range of services, from drug discovery and development, to release testing and regulatory compliance under ICH Q6B. As our client you can choose from the following services and analytical support from research to approval
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 our customers to use them in research or medical applications. We can undertake testing for both process-related impurities and product-related impurities.