Characterization & analysis of biotherapies

In recent years biopharmaceuticals (pharmaceuticals manufactured by biotechnological methods) have become successful medicinally and commercially.

Biopharmaceuticals are now the fastest growing market segment of the drug industry and include therapeutic proteins, fusion proteins, monoclonal antibodies, and antibody-drug conjugates. These are all large complex molecules, up to a thousand times larger than 'conventional' small molecule drugs. Biopharmaceuticals demand highly sophisticated analytical workflows for their analysis and characterization. Thermo Fisher Scientific offers all tools for the biopharmaceutical discovery, characterization, development, and control.

Biopharmaceutical characterization features

Chromatography Built for Biopharmaceutical Characterization

Biopharmaceutical characterization subtopics

Aggregate and Charge Variant Analysis

The development of biological therapeutics requires the development of a stable, well-characterized cell line. Identification of suitable antibody clones with the required expression levels is a laborious screening process that can take many months. Furthermore, antibody screening may involve multiple clone characteristics (such as titer and number/type of variants), meaning that multiple instrumentation techniques may be required. We have all of the tools that you need, for every step of the screening and selection process.

Biologics Quantitation

The accurate determination of pharmacokinetic properties of biologic molecules is one important part in the development process of biotherapeutic drugs. Currently, enzyme-linked immunoassays (ELISA) are the gold standard to measure the concentration of therapeutic antibodies and protein biomarkers, but they require lengthy development of custom antibodies and can be prone to severe matrix effects, resulting in inaccurate measurements.