Development of monoclonal antibody (mAb) therapeutics requires in depth knowledge of the product quality attributes critical for the safety and efficacy of the drug candidate. Therapeutic mAb's expressed in mammalian cell lines are heterogeneous molecules and contain product variants and impurities that may impact target binding, effector function activity, pharmacokinetic profile, and immunogenicity.  The cell culture conditions, harvest process, downstream purification and formulation stability may all contribute to the heterogeneity of the final product. Examples of these include amino acid sequence variants, glycosylation variants, product aggregates and particulates, and chemically modified species (e.g. oxidation, deamidation, et.al.). Consequently, appropriate understanding and assessment of these critical attributes is necessary to develop robust manufacturing processes that deliver consistent product quality. Strategies for control and monitoring of biologically relevant mAb heterogeneity will be presented and discussed.

Control and monitoring of therapeutic mAb heterogeneity during process and product development

248th National Meeting (2014)

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