9531255 Trnovsky During the last two decades, manipulation of DNA for the production of recombinant proteins has become a cornerstone of the biotechnology industry, and the recombinant proteins are now widely used as research reagents as well as therapeutics. Transfected cell line development however, can take as long as six months and can cost in excess of $100,000,000. In the emerging field of cellular therapeutics, patient cells are isolated, transfected, and expanded ex vivo, or outside the body, and then reinfused or encapsulated in implantable devices. Since the quality of the cell population is critical to therapeutic outcome, new separation approaches have become vital to treatment success. This Small Business Innovation Research Phase II project from One Cell Systems outlines research to develop a rapid, high throughput method for screening transfected cells based on recombinant protein secretion. Using gel microdrop single cell encapsulation technology, a unique capture assay format, and fluorescence activated cell sorting; protein secretion of individual cells can be measured and high producer cells isolated and recovered for gene therapy or bioprocessing applications. As additional biotechnology based products move toward commercialization, methods which improve the efficiency of cell selection and enhance bioprocessing yields will increase in importance. This novel, platform technology is adaptable to several clinical diagnostic, drug discovery, and therapeutic applications. Production of recombinant proteins using transfected cell lines is a multibillion dollar industry currently dominated by US biopharmaceutical companies. Existing methods for selecting and expanding transfected cells are time consuming and highly variable. Successful completion of this research will result in improved cell screening for bioprocessing, drug discovery, and gene therapy applications.
