STTR Phase II: Commercial Cell-Free Technology for Insulin-Like Growth Factor I (IGF-I) Production

Fundamental Applied Biology, Inc., Menlo Park CA

Investigators

Abstract

This Small Technology Transfer Innovation Research (STTR) Phase II project proposes to develop a cell-free process to produce insulin-like growth factor I (IGF-1). Prior Phase I work showed production of IGF-1 in very high yields (i.e. 800 ug/L) by a careful control of the environmental conditions and the catalysts that were used. These results show that not only the cell-free production of IGF-1 is technically feasible, but also that cell-free technology may be an important method for the production of any disulfide-containing protein that is difficult to produce in bacterial systems. The Phase II project will focus on quality control (that is, product characterization and optimization), reaction scale-up, and cost reduction. The cell-free process potentially offers high capital productivity along with unprecedented control over the conditions present during protein expression and folding. Both attributes are especially important for molecules such as IGF-1 that are intended for price-sensitive markets and that are both difficult to fold and are also subject to a variety of deleterious product modifications. The commercial application of this project will be in the area of biopharmaceuticals, for the cell-free production of an important protein drug, IGF-1, and potentially for the production of other important therapeutic proteins. The cell-free process is a low-cost, rapid, flexible protein-manufacturing platform that is capable of scaling up from development through to final manufacturing and would remove critical manufacturing and production bottlenecks in protein based drug development efforts.