Monday, July 30, 2007
P18

Clone and Process Specific Impacts on Glycan Profiles and Potency of an IgG1-Derived Monoclonal Antibody

Diana K. Hoganson1, Jian Dong1, Craig Finnegan1, Angelia Reed-Bogan2, Bryan Harmon2, Josh Poorbaugh2, and Bhavin Parekh2. (1) Bioprocess Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, (2) Biopharmaceutical Research and Development, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285

MAb1 is a humanized monoclonal IgG1 antibody expressed in K1 CHO cells under the glutathione synthetase expression system. The therapeutic mechanism of action is attributed to an effector function – activation of natural killer cells to alleviate undesired cell growth. Cell line generation culminated with clones which differed in product quality attributes, namely the fucosylation profile and bioactivity, assessed using the antibody-dependent cell-mediated cytotoxicity assay. Both the clone and the process were observed to impact these product quality characteristics, suggesting that MAb1 could be produced to meet a targeted activity level. The relationship between product quality and process or clone specificity will be discussed.

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