Sutro Biopharma’s core technology consists of a cell-free protein expression system (XpressCF™ and XpressCF+™) based on <i>Escherichia coli </i>extract, which has been developed for the expression of antibodies, bispecific molecules, cytokines and other proteins in a wide range of expression conditions. The XpressCF+™ system allows for the incorporation of a non-native amino acid, para-azidomethyl-L-phenylalanine (pAMF), to enable site-specific conjugation. This unique protein expression system allows for expedited scale-up from bench-scale to manufacturing-scale, shortening the time between molecule discovery and clinical development. To simplify and streamline cell-free harvest operations, optimized flocculation conditions were developed to enable high-capacity product recovery. Presented here is a comprehensive screening of multiple cationic polymer size variants across various pHs, temperatures, and flocculation time conditions suited for manufacturing scale-up. Depth-filtration capacity, product quality and yield were considered as response factors of varying the concentration and type of cationic polymer tested. Clearance of cationic polymers has been established across multiple chromatography and TFF steps to de-risk potential carryover into drug product.

Flocculation optimization for a scalable cell-free harvest process

2019 Spring National Meeting

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