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 committed to 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 significant 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. In addition, 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.
About iBio, Inc.
iBio, a leader in developing plant-based biopharmaceuticals, provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CDMO, LLC in Bryan, Texas. The facility houses laboratory and pilot-scale operations, as well as large-scale automated hydroponic systems capable of growing over four million plants as “in process inventory” and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year.
iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The Company’s pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the Company’s proprietary gene expression technology, is the Company’s lead therapeutic candidate being advanced for IND development.
Further information is available at: www.ibioinc.com
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