IDENTIFICATION & CHARACTERIZATION

  • 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.

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