Characterization of Therapeutic Proteins for Biological Drug Development

Biological drugs, including monoclonal antibodies, fusion proteins, and peptides have emerged as promising therapeutics. Monoclonal antibodies in particular, due to their specificity, relatively long half lives, and low toxicity have entered the clinic to treat a variety of diseases ranging from cancer to inflammatory diseases. Analytical characterization of antibodies required during various stages in the development of biopharmaceuticals, include for example, screening for titer, aggregation, and heterogeneity, including charge variant analysis.
Heterogeneity introduced during the manufacture of biological therapeutics continues to pose a challenge to characterization of these proteins. Follow-on biologics, especially complex proteins such as monoclonals, require extensive comparison between innovator products and their biosimilars, and place further demands on analytical techniques.
In this webinar, participants will discuss advances in instrument capabilities and techniques that provide reliable, consistent and faster analytical methods, including the performance of Agilent 6550 iFunnel Q-TOF for intact protein analysis and peptide mapping. Several case studies to introduce the application of various analytical techniques for therapeutic protein characterization, particularly monoclonal antibodies, will also be presented. These techniques support comparability, similarity and stability studies required during biological drug development.

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