Providence, RI. Tuesday, July 8th, 2014 A Public-private partnership resulted in the development of a new web-based tool that will to help manufacturers of protein-based therapeutics improve the safety of their manufacturing processes, avoiding problems that caused the FDA to suspend a clinical trial in 2012 for a Factor IX protein.
The tool predicts the likelihood that product-associated impurities will induce an adverse response in patients. A description of the new tool, known as CHOPPI (for CHO Protein Predicted Immunogenicity), will be published in the Biotechnology and Bioengineering journal this week.
Protein therapeutics are often produced in living host cells such as Chinese Hamster Ovary (CHO) cells. Despite ongoing production process improvements, CHO host cell proteins (CHOPs) can sometimes contaminate the final product. Even at very low levels, these CHOPS may compromise the safety and efficacy of the biologic product. Anne De Groot, MD, EpiVax CEO, stated; “given the enormous growth in cell-culture-derived proteins for the treatment of human diseases, the immunogenicity of culture contaminants has emerged as a significant concern for the biotechnology industry.” With increased prevalence of these products in medical applications, “building knowledge about immune recognition of host cell proteins is a very important endeavor for EpiVax and industry leaders to undertake”, as one biopharmaceutical industry professional explained. EpiVax and Dartmouth researchers expect that this tool will have significant value for protein engineers looking to assess safety risks quickly and accurately.
CHOPPI was developed in a collaboration between researchers at Dartmouth College, University of Rhode Island and EpiVax Inc. CHOPPI allows users to search through a collection of proteins and genetic information on CHO cells and quickly access data on how immunogenic and “human-like” a protein is in comparison to others.
EpiVax plans on developing the tool further to include other common production host cell lines. The current beta version of CHOPPI is still available for academic users at the through the University of Rhode Island at http://www.immunome.org/choppi/. CHOPPI and will be available for commercial use through EpiVax (http://www.EpiVax.com/CHOPPI). For more information on accessing CHOPPI for commercial use contact bwinterroth@epivax.com
The CHOPPI tool is the direct result of URI investment in public private partnership with EpiVax, Inc at the Institute for Immunology and Informatics. Dartmouth Professor and CHOPPI Co-designer Dr. Chris Bailey Kellog spent one year at the iCubed, working with Director and URI Professor, Dr. Annie De Groot. De Groot’s company, EpiVax, developed the concept and contributed EpiMatrix analysis of the CHO genome to the collaboration. Graduate student Andres Gutierrez helped develop the tool as part of his doctoral research at URI.
About EpiVax
http://www.EpiVax.com
EpiVax, Inc., located in Providence, Rhode Island, USA, is a biotechnology company focused on the development of vaccines and biologic therapies. EpiVax is one of the world’s leading innovators in the field of Immunogenicity Screening. The company uses proprietary immunoinformatics tools to screen protein therapeutics and to de-immunize these drugs so as to reduce adverse effects in the clinic. EpiVax is also developing the novel Tregitope technology as an immune-modulating therapy for use in autoimmune and inflammatory conditions.
About the Institute for Immunology and Informatics
http://www.immunome.org
The Institute for Immunology and Informatics (iCubed) was established in 2008 as part of the University of Rhode Island’s emerging biotechnology program. ICubed applies cutting-edge bioinformatic tools to accelerate the development of treatments and cures for a number of diseases such as hepatitis C, Lyme disease and Dengue fever. The Institute also aims to quickly make these tools available to the global research community for the development of vaccines for other infectious diseases.
About Dartmouth College
http://dartmouth.edu/
Founded in 1769, Dartmouth is a member of the Ivy League and consistently ranks among the world’s greatest academic institutions. Dartmouth has forged a singular identity for combining its commitment to undergraduate liberal arts and graduate education with research and scholarship in the Arts & Sciences and its three leading professional schools—the Geisel School of Medicine, Thayer School of Engineering, and the Tuck School of Business.
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