Generation of high productivity cell lines remains a major bottleneck in therapeutic antibody engineering. To address this need, we have developed a proprietary Antibody-Membrane Switch (AMS) technology that facilitates rapid cloning of cell lines for commercial production of antibodies. This technology streamlines identification of high-productivity clones, shaving at least 6-8 months off timelines using conventional cell culture techniques employing gene amplification methodology. More importantly, AMS technology permits assessment of multiple critical cell line attributes besides productivity in an early stage, greatly simplifying downstream process development. Preliminary studies demonstrate reduction to practice of the underlying AMS methods. In Phase I, AMS will be optimized using two biosimilar antibodies. In Phase II, the optimized methods will be extended to antibody library screening. AMS technology permits the discovery of antibodies to be seamlessly linked to downstream cell line development providing the basis for rapid, facile cell line production as well as a novel antibody-discovery platform.
Therapeutic antibodies are expensive, in part due to the costly, time-consuming steps involved in the development of stable, high-expressing cell lines for production. We describe a novel cell line development method that utilizes alternative splicing of a membrane-anchored Fc domain and florescence-activated cell sorting (FACS) to rapidly identify antibody production cell lines with greatly reduced time and cost. The same platform can also be used to screen affinity maturation or synthetic antibody libraries and facilitates seamless transformation into production cell lines.