iBio Expands Product Development Capacity of cGMP Plant
NEW YORK, NY -- (Marketwired) -- 11/10/16 -- iBio, Inc. (NYSE MKT: IBIO), a leading provider of plant-based biotechnology for developing and manufacturing biological products, announced completion of expanded product development capacity of its subsidiary, iBio CMO LLC, for the production of pharmaceutical proteins in hydroponically-grown green plants. This expansion enables iBio CMO's use of iBio proprietary technologies to conduct concurrent product development work for multiple clients in multiple product classes with time-saving transitions from laboratory-level feasibility and testing through cGMP production of active pharmaceutical ingredients for toxicology studies and phase 1 human clinical trials.
"An important consideration for many of our clients and prospective clients is our ability to save them time during critical stages of their proprietary product development programs," said Dr. Barry Holtz, iBio's senior vice president of product development and manufacturing. "We can provide definitive technical answers faster than conventional mammalian cell-based systems and then move directly into larger scale production. This avoids engineering and reengineering mammalian cell lines and dealing with the scale-up issues associated with traditional CHO cell production."
iBio is currently engaged in development of several vaccine and therapeutic candidates for third party clients and is significantly expanding its commitment to the monoclonal antibody product category. The pilot plant expansion enables the company to remain fully committed to its own proprietary anti-fibrosis therapeutics program while taking on promising programs with quality clients.
About iBio, Inc.
iBio is developing proprietary products for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, produced using the Company's proprietary gene expression technology, is the first product candidate from this program being advanced for IND development. The Company also offers proprietary products and product licenses to others based on its proprietary technologies, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines.
iBio CMO LLC is a 70 percent subsidiary of iBio jointly owned with affiliates of Eastern Capital Limited for development and large-scale manufacture of plant-made pharmaceuticals. The iBio CMO multiproduct facility includes laboratory and pilot-scale operations as well as large-scale automated hydroponic systems capable of growing over 4 million plants as "in process inventory" and producing over 300 kilograms of finished therapeutic protein per year. This translates into more than a half million doses per year of a typical therapeutic antibody and approximately 50 million vaccine doses every three weeks. Facility capacity can be doubled by adding additional plant growth equipment in a space already reserved for that purpose. iBio CMO's lease includes the right to develop another facility on the balance of the leased property that would have the effect of quadrupling capacity from the current level. iBio CMO offers a range of pharmaceutical product and process development, analytical, and manufacturing services.
In Brazil, iBio has formed a subsidiary company, iBio do Brasil Biofarmaceutical Ltda., and has been collaborating with the Oswaldo Cruz Foundation (Fiocruz) to develop a recombinant yellow fever vaccine based on iBio technology. Further information is available at: www.ibioinc.com.
STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
Source: iBio, Inc.
Released November 10, 2016