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FRAUNHOFER CENTERS IN NEWARK, DE, AND AT BOSTON UNIVERSITY DEVELOP PLANT-BASED VACCINE FACTORY BASED ON PROPRIETARY EXPRESSION TECHNOLOGY OF IBIO, INC.

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  Fraunhofer Center for Molecular Biotechnology in Newark, Delaware, the Fraunhofer Center for Manufacturing Innovation in Boston, Massachusetts, the Boston University College of Engineering, and the biopharmaceutical company iBio, Inc. in Newark, Delaware, announced today that they have developed a fully automated, scalable factory that uses natural (non-genetically-modified) green plants to efficiently produce large quantities of vaccines and therapeutics within weeks.

Such a rapid vaccine production facility will play a crucial role in addressing and containing future pandemics and emerging biological threats.

This first-of-a-kind, plant-based vaccine factory, takes advantage of plant viral vector technology developed by Fraunhofer CMB for the biopharmaceutical company iBio. The technology has the capability to produce specific proteins within the leaves of rapidly growing plant biomass. The factorys robotically tended machines, designed by Fraunhofer CMI, plant seeds, nurture the growing plants, introduce a viral vector that directs the plant to produce a target protein and harvest the biomass once the target has accumulated in the plant tissue. Traditional methods of vaccine production can take many months. Our plant-based technology provides the means for rapid, large scale production of vaccine material in a cost effective manner, said Dr. Vidadi Yusibov, Executive Director of CMB. This technology has the potential to revolutionize how biological materials are manufactured. By partnering with CMI and Boston University, we engineered agricultural and molecular biology into scalable automated processes to es
tablish the first cGMP (current Good Manufacturing Practices) facility for plant-based protein production.

The factory was designed to be time, cost and space efficient. It has the capacity to grow tens of thousands of plants in one batch. The plants are grown in multi-plant trays that are used to handle and transport the plants to the different processing stations. To automate the process, robots glide up and down a track, tending the plants  delivering trays from the lighted, irrigated growth modules to each processing station at the appropriate time. In order to quickly produce large quantities of vaccine material or other protein-based medicines such as antibodies in compliance with cGMP, it was necessary to develop a consistent, repeatable process. We have taken a biological process and turned it into an industrial process said Andre Sharon, a professor of mechanical engineering at Boston University and Director of CMI. Even though the process of making vaccines from plants includes many aspects of traditional horticulture such as growing, watering and harvesting, we have developed a way to automate thos
e functions to quickly, safely and cost effectively scale up from a few milligrams in a laboratory setting to the many kilograms that would be required in case of a pandemic, said Sharon. Everything was designed from the ground up. The process is faster, less expensive, safer, and does not require the sophisticated culturing or fermentation necessary in the current vaccine production

processes.

This unique, plant-based vaccine factory resulted from a three-year collaboration between the Fraunhofer USA Centers in Delaware and Boston, which are affiliated with Fraunhofer-Gesellschaft, Europes largest applied research organization, and Boston University. This is a perfect example of coupling engineering expertise and scientific advancement to cost-effectively meet a societal need, remarked Robert Brown, president of Boston University and a chemical engineer. It is a model for collaboration that we strongly believe in on our campus, as they do at Fraunhofer as well.

Support from the Defense Advanced Research Projects Agency (DARPA) under the Accerlated Manufacturing of Pharmaceuticals program, along with funding from the state of Delaware were key in facilitating the design and construction of the pilot facility in Newark, Delaware. I am impressed by Fraunhofers innovation and commitment to excellence at the scientific and business levels. I am hopeful that Fraunhofers promising discoveries will advance vaccines and pleased that these biological state-of-the-art developments are taking place in Delaware, said Delaware Governor Jack Markell.

We believe the new factory in Delaware demonstrates that public health officials will finally have a rapid, high-performance vaccine production technology to use against emergent threats, said Robert Erwin, President of iBio. We also expect scalability and efficiency of the expression and manufacturing technology to lead to broad commercial applications.

About Fraunhofer

Fraunhofer-Gesellschaft is the leading organization for applied research in Europe with 59 research institutes and 17,000 employees. Fraunhofer USA is a wholly-owned subsidiary headquartered in Plymouth, Michigan with research centers that collaborate with major universities throughout the U.S. Fraunhofer Center for Molecular Biotechnology develops safe, rapid and economical alternatives for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge technologies to assist the diagnosis, prevention and treatment of human and animal diseases. The Center houses individuals with expertise and excellence in plant virology, pathology, molecular biology, immunology, vaccinology, protein engineering, and biochemistry. Fraunhofer Center for Manufacturing Innovation is located on the campus of, and partnered with Boston University. The Center was established in 1995 to serve as a bridge between academic research and industrial needs. Working with BU faculty and stu
dents, the engineers and scientists in the Center scale up basic research into advanced technologies. The focus of Center is on development of next-generation instruments and high precision automation systems for the biotech/biomedical, photonics and renewable energy sectors.

About Boston University

Founded in 1839, Boston University is an internationally recognized private research university with more than 30,000 students participating in undergraduate, graduate, and professional programs. BU consists of 17 colleges and schools along with a number of multi-disciplinary centers and institutes which are central to the schools research and teaching mission. The BU College of Engineering offers bachelors, masters and doctoral degrees in the departments of Biomedical, Mechanical, and Electrical and Computer Engineering. It also has two interdisciplinary divisions focused on research and graduate education: the Division of Systems Engineering; and the Division of Materials Science & Engineering.

About iBio

iBio, Inc. is a biopharmaceutical company commercializing its proprietary technology, the iBioLaunch platform, for the production of biologics including vaccines and therapeutic proteins. The iBioLaunch platform uses transient gene expression in green plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited to infectious disease applications where speed, scalability, and surge capacity are important. iBios strategy is to utilize its technology for development and manufacture of its own product candidates and work with both corporate and government clients to reduce their costs during product development and meet their needs for low cost, high quality biologics manufacturing systems. iBio owns technology developed at the Fraunhofer USA Center for Molecular Biotechnology, and continues to sponsor development and refinement of the technology for broad applications in human healthcare. Further information is ava
ilable at www.ibioinc.com.