Biotherapeutics or Biologics are the fastest growing segment of the pharmaceutical industry's discovery and development pipeline.

 Monoclonal antibodies dominate the market today, but these are just one of many types of biotherapeutic where mass spectrometry is important in characterization and analysis.

Biologics Characterization 


Recent cutting-edge biotherapeutic strategies, such as antibody drug conjugates, combine the strengths of small molecule and protein-based agents to deliver therapeutics that possess the biological specificity of antibodies, and the chemical versatility of small molecules. To cope with the complexity of Biologics, we innovate to provide greater efficiencies for any organization. Whether it is advanced characterization of biologics or the profiling of post-translational modifications, we provide a range of solutions.

Molecular weight determination of intact proteins is used from clone selection, to QC. The most advanced detection and data processing by LCMS can be applied to this for the detection of low level isoforms. Peptide mapping for characterization of biopharmaceuticals is indispensable to the analytical scientist. From informatics tools that process data automatically, vizualizations that confirm Amino Acid sequence, to systems that provide LC separation for the most advanced mass spectrometry systems, it is now possible to rapidly and simply identify and quantify post-translational modifications (PTM) as part of routine analysis. Disulfide bond mapping, glycopeptide profiling, and analysis of released glycans can all be performed on the same platform as peptide mapping, providing an efficient use of resources. For characterization that may better inform the discovery and pipeline of an organization, tools for sequence variant analysis are indispensable to prevent inappropriate biologics being taken forward to production. The tools used in comparability of biologics can also be applied to biosimilars, which need extensive physicochemical analysis.

As regulatory guidelines evolve with time, it is also important to identify and map low level modifications, variations, and unexpected impurities that may result from the production of recombinant proteins in mammalian cell cultures.

Host Cell Protein (HCP) analysis offers valuable information to any organization concerned with patient safety, or with gaining process efficiency Sequence Variant Analysis (SVA) can help avoid progressing tan inappropriate cell line

Innovative new techniques to determine impurities are always part and parcel of our ethic.