Antigen-binding fragments (Fabs) are novel formats in the growing pipeline of biotherapeutics. Sharing similar features to monoclonal antibodies (MAbs) with regard to expression, Fabs are considered as unchallenging for upstream development. Yet for downstream processing, the mature MAb downstream purification platform is not directly applicable. New approaches need to be found to achieve a lean purification process that maintains quality, productivity, and timelines while being generically applicable independent of the expression system. The work presented in this poster show the development of a new affinity chromatography medium (resin) suitable to support cGMP manufacturing of lambda Fabs. We show that using this novel chromatography medium for the capture step, a purification platform for lambda Fabs can be established.

Development of a novel affinity chromatography medium for platform purification of lambda Fabs

249th National Meeting (2015)

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