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


Liquid Chromatography for every Biopharmaceutical Analytical Workflow

Antibodies are becoming increasingly important in the development and manufacture of drugs globally. Biopharmaceutical companies have a requirement to accurately measure aggregation to ensure that levels are minimized.


The world of biotherapeutic characterization is undergoing a revolution. Development of evermore complex protein-based therapeutics places rigorous demands on analytical technologies. 


With the current market value for biopharmaceuticals standing at more than $150 billion, the need for higher throughput, more in-depth characterization techniques for biologics is accentuated. Can recent technological advances in UHPLC meet the practical and regulatory requirements of the biotherapeutic development chain?

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Characterizing Therapeutic Monoclonal Antibodies

Accounting for the inherent heterogeneity of monoclonal antibodies is essential to ensure production of consistent and safe therapeutics and, in light of this, there is an array of chromatographic and supporting regulatory systems.

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.