Biologics formulation screening and accelerated stress studies are essential in the development of biotherapeutics. These experiments require the analysis of many samples to assess the stability of the protein in the different formulations. Typically each assay is performed manually, using individual instruments, which is a bottleneck in the development process. Freeslate is introducing a family of CM Protégé Bioformulation Assessment Systems for the automated analysis of protein formulations for visible particles, turbidity, color, viscosity, and pH. The CM Protégé Bioformulation Assessment Systems are robust and easy-to-use with a simplified User Interface which supports the requirements of biologics preformulation/formulation development laboratories. In a collaborative study with a biotechnology company, the analytics were used to measure visible particle, turbidity, color, and viscosity from protein formulations after an accelerated stress study. The formulations tested varied widely in pH, buffer species, and excipient levels.


Speaker: David Yamane (Product Marketing Director, Life Science - Freeslate)

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