The vast experimental space that needs to be explored during the development of a biopharmaceutical purification process has led to the widespread adoption of High-Throughput (HT) technologies. These HT technologies can also be used to support knowledge-based development of chromatographic separation processes, allowing to step away from traditional platform processes. Such an approach requires efficient techniques to determine properties of the product and the impurities to be removed (i.e. charge, hydrophobicity, size, and adsorption isotherms). In order to be fast and efficient, small quantities of material should be used and this leads to miniaturization of experimental techniques and devices. This paper will present a state-of-the-art High-Throughput Process Development (HTPD) approach, emphasizing miniaturized, recently developed chip based approaches for the purification process development for the production of biopharmaceuticals.

Miniaturized techniques for high throughput biopurification process development

253rd National Meeting (2017)

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