Abstract

Biopharmaceutical process development at the preclinical and early clinical stages often involves the lengthy and costly adaption of low-throughput column-based purification methods originating in lead or candidate molecule development to produce larger potential therapeutic agent batches with favorable yield, purity, and biological activity. One prominent early-stage strategy to increase throughput in process development is the miniaturized screening of chromatographic conditions using 96-well plates filled with chromatography resin, andusing either empirical or in silicodesign-of-experiments (DoE) methods. Here we describe the development of a Biomek i7 Dual Hybrid workstation solution to automate the chromatography resin-based purificationworkflow, including buffer production, desalting, and hydrophobic interaction chromatography purification, with CytivaPreDictor™plates pre-packed with CytivaBioProcess™chromatography resins.