High-throughput technology combined with statistical analysis has revolutionized how chromatographic processes for the purification of recombinant proteins are developed by enabling a thorough and systematic investigation of the process and quality parameter dependencies. An even higher level of process understanding and performance prediction capability is achieved through the regression of thermodynamic parameters from the experiments and their use in mechanistic models, but the  resolution of most current techniques is only suitable for the characterization of samples of low complexity.Integration of analytical techniques from the field of proteomics with high-throughput screening techniques has been proposed to allow the determination of physico-chemical parameters directly from crude samples, allowing to characterize not just the recombinant protein products but also process related impurities such as host cell proteins.We present a three-dimensional characterization approach centered around pore-size characterized micro-columns packed with industrial grade chromatography resins and demonstrate its application to complex model samples and real fermentation supernatants.

Multiplexed high-throughput characterization of cell culture supernatants

247th National Meeting (2014)

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