Originally introduced to accelerate process development and to meet aggressive timelines, high throughput process development (HTPD) is a broad term that captures numerous experimental techniques. This presentation discusses some core high throughput techniques that have been consistently used to develop biopharmaceutical chromatographic processes. Protein solubility and resin characterization were performed using 96 well plates in combination with a liquid handling system to determine solubility maps, binding isotherms and binding maps. Chromatographic selectivity and resolution were determined using the 96 well plate fractionation capabilities of a chromatographic unit in combination with automated analytical methods for host cell proteins and aggregate analysis. The dynamic binding capacity for harvest materials was measured by using a high throughput analytical titer method. The integrated use of these HTPD techniques for chromatographic process development is discussed for different chromatographic modes. Their value is derived from the fundamental information linked to a mechanistic understanding of chromatography that they provide, resulting in improved process robustness, quality and yield as well as reduced development timelines.<br/>

Integration of platform high throughput technologies in biopharmaceutical downstream process development

251st National Meeting (2016)

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