The control of Host Cell Proteins (HCP) has become one of the major challenges in product development due to the complexity of HCPs and the lack of understanding of individual components.  Current practice is to use bio-analytical methods (e.g. ELISA) that yield a single result to assess �total� HCP levels, and to optimize processes to ensure low HCP values with the single assay. A novel approach will be presented for visualization of individual HCP species in purified monoclonal antibody samples using 2-dimensional SDS-PAGE gels and identification of those HCPs using 2-dimensional Mass Spectrometry (MS)-based proteomics. In particular, a multi-step product depletion method was developed to remove product and product-variants from the purified monoclonal antibody preparation. This approach was used to assess the impact of purification process changes on a specific population of residual HCP species. Following the identification of co-purified HCPs, an in-silico immunogenicity assessment was performed.

Assessment of the impact of purification process on the host-cell protein population and distribution

245th National Meeting (2013)

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