Understanding the size distribution in biological therapeutics is important to providing high quality drug products to the market. With the increase of diversity in modalities in biological therapeutics, variety of analytical separation techniques has been used during the product development to monitor the process development and to characterize the final bulk product. Analytical ultracentrifugation, particularly with the sedimentation velocity method, has been one of the important tools in providing either orthogonal or primary characterization for certain macromolecular assemblies. Multiple examples will be included to illustrate the use of this technique on large protein aggregates, nanoparticles, virus-like-particles, viral capsids, etc.

Application of analytical ultracentrifugation in biopharmaceutical development: Separation and characterization of large molecular assemblies

254th National Meeting (2017)

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