To meet the needs of today's fast and competitive market, biopharmaceutical downstream process development still heavily relies on empirically developed process designs, often sacrificing process efficiency for speed to market. Novel process development strategies, such as model-based purification process development, are being developed to overcome these shortcomings but require detailed knowledge of the physical-chemical and thermodynamic properties, not just of the product to be purified, but also of the contaminating host cell proteins.Multi-dimensional fractionation and characterization schemes based on techniques developed in the field of proteomics have been shown to be able to deliver some of these properties, while the resulting 'protein-maps' themselves already allow a rational choice of the purification strategy.We present how parallelized high-throughput chromatography can be applied within such a multi-dimensional characterization scheme allowing fast and cost efficient characterization of HCP interactions with industrial-grade chromatography resins and demonstrate its application to a complex CHO feedstock.

High-throughput crude feedstock profiling: The characterization of CHO host cell proteins

245th National Meeting (2013)

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