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Development of a novel affinity chromatography resin for platform purification of lambda fabs
Author(s) -
Eifler Nora,
Medaglia Giovanni,
Anderka Oliver,
Laurin Linus,
Hermans Pim
Publication year - 2014
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.1958
Subject(s) - downstream processing , downstream (manufacturing) , monoclonal antibody , affinity chromatography , chromatography , chemistry , manufacturing process , pipeline (software) , upstream (networking) , computer science , engineering , antibody , biology , biochemistry , materials science , operations management , operating system , enzyme , immunology , composite material , computer network
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. In a successful collaboration, BAC BV, GE Healthcare, and Novartis Pharma AG have developed 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. © 2014 American Institute of Chemical Engineers Biotechnol. Prog ., 30:1311–1318, 2014