Current Trends in the Analysis of Biologics, Biosimilars & Biobetters
Development and production of biopharmaceuticals is a growing segment of pharmaceutical industry. A thorough characterisation of therapeutic biomolecules is key for the successful submission of research and production data for regulatory approval of new drugs. The introduction of the first so-called biosimilars has further increased the demand for highly efficient analytical methods.
A decade after the introduction of the first ultrahigh-performance liquid chromatography (UHPLC) system, UHPLC has made its way into routine labs for the analysis of small molecules and active pharmaceutical ingredients (APIs). The use of UHPLC has triggered a remarkable increase in efficiency and throughput of LC and LC-MS methods, and there is an increased interest in applying UHPLC also to biopharmaceutical analysis.
The analysis of the aggregate content and charge heterogeneity are typical applications applied to characterize therapeutic proteins, such as monoclonal antibodies. Smaller peptides or the oligosaccharides of the glycan structure of a protein are typically analysed after enzymatic cleavage. Recently, the analysis of antibody drug conjugates (ADCs), bispecific antibodies, and therapeutic oligonucleotides by chromatographic methods gained attention to characterise these new drug formats.
The webinar will summarize current trends in UHPLC applications for biomolecules. Case studies will illustrate the potential of using UHPLC for applications, which are frequently used in development and production of biologics, biosimilars, and biobetters. New biocolumn developments supporting these techniques will be presented. Hyphenation of these LC Methods with sophisticated techniques such as mass spectrometric, light scattering, or Raman detection will also be covered.
Register today to learn more about the latest UHPLC technologies applied for the characterisation of biopharmaceuticals and discuss topics of interest with the experts.
Presented by
Judith Vajda,
Senior Lab Specialist
Judith has been involved in purification and analysis of biologics for years. She has a keen interest in applying new technologies for the chromatographic separation of immunoglobulins and related targets. She presented at several conferences, such as PREP, ISPPP, HIC/RPC, and the BioInnovation Leaders Summit. Judith holds a major in immunology and a diploma degree in technical biology from the University of Stuttgart.
