IDENTIFICATION & CHARACTERIZATION
Getting down to the nitty-gritty details…
We apply a systematic and multi-tiered approach to support identity testing and in-depth characterization of your product covering a wide array of analytical technologies, combining the high-resolution capabilities of chromatography and mass spectrometry with orthogonal methodologies such as electrophoresis.
We generate a comprehensive multi-level analytical dataset, including information regarding your intact molecule as well as its fragments, peptides and conjugated structures such as glycans, linkers and small molecules.
We deliver in-depth information on product-related characteristics, such as molecular weight, amino acid sequence and composition, structural integrity, epitope mapping & complex formation, higher order structure, aggregation, N- and O-glycosylations, disulfide bridges and other cysteine related variants, N-and C-terminal processing, deamidation, isomerization, oxidation, clipping, glycation or any other modification potentially occurring in your product.
We can monitor your molecule during upstream processing (e.g. fermentation and harvesting), downstream processing (e.g. holding steps, re-buffering and final concentration) and final formulation and provide comparability data across multiple batches (e.g. different campaigns, different manufacturing sites, before and after process changes)
We screen for and quantify potential impurities introduced by your host cells (e.g. HCPs, metabolites, lipids) or your production process (e.g. residual chemicals, leachables, extractables) using a targeted approach as well as untargeted (omics-based) screenings.