(410c) Downstream Separation and Scale-up Challenges for E.Coli-Derived Biopharmaceuticals – an Industrial Study on Development of an Antibody Fragment (Fab) Process

Monoclonal antibodies (MAb) are becoming powerful therapeutic agents for numerous diseases and accelerating the bioprocess development of these agents followed by GMP production for clinical evaluation is vital for their development. An industrial case study will be presented describing process development challenges for antibody fragment (Fab) expression in E.coli. The focus will be on development of a downstream process utilizing multiple sequential steps comprised of Cation exchange chromatography (CEC), Mercapto pyridine hypercel (MEP), Q -Sepharose and TFF unit operations. This presentation also will highlight the challenges of introducing Charge Induced Hydrophobic Interaction Chromatography (MEP), a new separation technology, in scale-up and clinical production settings which was critical for separation of product-related impurities. Approaches XOMA has utilized to accelerate Fab process development and clinical production also will be discussed.