This Small Business Innovation Research Phase I project aims to develop an antibody expression system that will dramatically reduce the cost of goods as well as the time required for the development of an antibody product. The ability of antibodies to bind to their targets specifically and with high affinity make them attractive therapeutic reagents for use in the treatment of many human diseases. In fact, a number of antibodies have recently reached the market place, and approximately 25% of the current biopharmaceuticals in phase III trials are antibodies. The manufacturing of antibodies, however, is expensive and technically challenging process requiring considerable time for process development. This is a result of the difficulties associated with generating protein products from mammalian cultured cell lines. In fact the single biggest factor determining both the cost of goods and the time to market is the choice of expression system and the characteristics of the antibody producing cell line. This proposal describes a method for the generation of novel cell lines with high productivity that can be generated quickly and reproducibly. The reduction in the costs of manufacturing and the time required for development will greatly facilitate moving antibody products to the market. PROPOSED COMMERCIAL APPLICATIONS: The manufacturing of an antibody as use as a medicinal reagent can represent the majority of the cost of goods of the product. Reduced costs for the production of antibodies can directly result in increase profits for a company. A manufacturing system that reduces the time a cell line is in development also has important financial consequences. The innovation Abgenix is attempting to develop would allow for the rapid generation of antibody producing cell lines capable of high levels of antibody expression suitable for large scale manufacturing. Abgenix will initially market this technology to its corporate partners and intends to also incorporate the technology in the development of its own products
