Biopharmaceutical Characterization Information
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
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?
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.
Biopharmaceutical characterization subtopics
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.
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.
The use of biotherapeutics has led to an increased demand for methods to characterize their glycosylation structures. It is important for drug safety and efficacy to know what glycans or oligosaccarides are present and how they are linked to the protein. Biopharmaceutical manufacturers must demonstrate control in the glycosylation of biologics. We have tools and leading technologies to support you in meeting these requirements.
Peptide mapping is a critical step during biotherapeutic characterization. The so called “bottom up” characterization of proteins by digestion to their constituent peptides is necessary to ensure a full understanding of the protein.