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Structure and Sequence Determinants of Nonspecificity and Aggregation of Therapeutic Antibodies

Millions of dollars are spent annually on the development of therapeutic antibodies directed against a wide variety of diseases. In the development process, many promising therapeutics must be abandoned as they clear at a rapid rate from the body due to nonspecific interactions or aggregate in the production process. Currently there is no effective way to predict human clearance other than costly animal trials late in the development process.

It is first the goal of my research to develop an in vitro assay which can effectively measure the nonspecificity and aggregation potential of therapeutic antibodies and predict their clearance rates in humans at an early stage in the development process. From this assay I plan to screen a wide panel of potential antibody clones to elucidate the structure and sequence determinants which lead to high levels of nonspecificity and aggregation.