Antibody drug conjugates (ADCs) have a great potential to increase the biopharmaceutical drug efficacy. Unfortunately, this great potential currently is explored at high costs due to the complexity of the manufacturing process. Especially the purification of immunoglobulins carrying different ratios of cytotoxic drugs requires the use of non-efficient chromatographic steps at narrow operation windows. The exploration of an innovative ion exchange resin enabled us to reach an efficient DAR (drug antibody ratio) species separation without applying high conductivity and/or organic solvents. Moreover, we could improve the quality of commercially available ADCs by preparative separation of each individual DAR species, regardless their manufacturing origin. The application of ion exchange chromatography showed significant economic advantages compared to hydrophobic interaction chromatography, assuring high product recovery rates without influencing ADC’s efficiency. Additionally, we were able to upscale such separation from analytical column format to preparative mode at minimal process development efforts defining a broad window of operation and reflecting the later ease of use and templatability of such method. 

Enhanced selectivity of ion exchange resin for ADC polishing

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.