iBio announced the expansion of its CDMO capabilities and services to include the development and cGMP manufacturing of Fc fusion proteins for therapeutic pharmaceutical applications.
Fc fusion proteins are typically created using Chinese hamster ovary (CHO) cells and combining the active portion of a desirable protein with the naturally stable “tail portion” of an antibody protein. The resulting hybrid protein can exhibit important commercial and clinical advantages over both the original protein and traditional antibodies.
Numerous Fc fusion proteins have been approved by the FDA for a range of applications including colorectal cancer, macular degeneration, hemophilia, and others. Additional Fc fusion proteins are in various stages of research and clinical development.
iBio is now able to offer clients engaged in the clinical development of proprietary Fc fusion products the use of iBio’s proprietary, plant-based technologies and facilities to achieve the same competitive advantages it offers its antibody clients. These include more rapid and economical evaluation of multiple lead candidates during early development and time and cost savings during each stage of scale up of production from laboratory quantities to cGMP pilot lots for GLP toxicology and human clinical trials and then for commercial manufacturing. By using iBio’s proprietary plant-based technology instead of CHO or other mammalian cell technologies, iBio generates monoclonal antibody vectors entirely free of any viral transforming functions or contamination from parental lines. iBio’s “lab to launch” capability and capacity for biologics development now extends to this important Fc fusion therapeutic protein category.
“We have proven Fc fusion manufacturing success with our own proprietary Fc fusion protein candidate for the treatment of fibrotic disease and with other Fc fusions, and now look forward to assisting others with promising Fc fusion proteins in preclinical and early clinical development,” said Dr. Barry Holtz, President of iBio CDMO.