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Webinar|De-risking the Development of Tomorrow’s Medicines with Advancing Analytical Characterization Capabilities

March 13, 2024

Virtual

LSC Webinar

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Join our Webinar – Wednesday, March 13th @ 11:00 AM EDT

Jason Barker, Ph.D, Director, Analytical Development, Analytical Methods Transfer and Formulation Development, FUJIFILM Diosynth Biotechnologies U.S.A., Inc is presenting on De-risking the Development of Tomorrow’s Medicines with Advancing Analytical Characterization Capabilities.

A deep understanding of a biotherapeutic molecule’s structural properties, as well as product-related and process-related impurities, has traditionally been an expectation for regulatory submissions. Early evaluation of these attributes, or the personality of the molecule, can also help drive decision-making during the product development cycle and support investigations of atypical results. As the complexity of biotherapeutics grow to include molecules such as fusion proteins and bispecific molecules, new analytical challenges arise that necessitate an evolving analytical toolbox. This presentation will focus on the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver tomorrow’s medicines in a safe, compliant, and efficient manner.

Key learning objectives

  • Complex biotherapeutics have diminished the use of platform methods and increased the demand for more advanced analytics
  • The importance of evaluating the “personality of a protein” along the process development trajectory beyond the characterization data expected in regulatory submissions
  • Generating expanded product knowledge to drive decision-making and enable efficient and robust process development