Newswise — PROVIDENCE, R.I. – July 8, 2014 - A public-private partnership born out of the University of Rhode Island’s Institute for Immunology and Informatics (iCubed) has resulted in a new web-based tool designed to help manufacturers of protein-based therapeutics improve the safety of their manufacturing processes, avoiding problems that caused the U.S. Food and Drug Administration to suspend a clinical trial in 2012.
The tool, known as CHOPPI (Chinese Hamster Ovary Protein Predicted Immunogenicity), predicts the likelihood that product-associated impurities will induce an adverse response in patients. A description of the new tool will be published this week in the journal Biotechnology and Bioengineering.
CHOPPI is the result of a collaboration among researchers at the University of Rhode Island, Dartmouth College and Providence-based computational immunology company EpiVax, Inc. EpiVax is owned by URI Research Professor Annie De Groot, who is also the director of iCubed, a vaccine research institute located at the University’s Feinstein Providence campus.
Dartmouth professor and CHOPPI co-designer Chris Bailey-Kellogg spent a year at iCubed working with De Groot. As part of their roles in the collaboration, EpiVax contributed EpiMatrix analysis while Bailey-Kellogg developed the CHOPPI web server. URI graduate student Andres Gutierrez Nunez helped develop the tool as part of his doctoral research.
Protein therapeutics are often produced in living host cells such as Chinese hamster ovary cells. Despite ongoing production process improvements, these host cell proteins can sometimes contaminate the final product. Even at very low levels, the proteins may compromise the safety and efficacy of the biologic product. The new tool allows users to search through a collection of proteins and genetic information on Chinese hamster ovary cells and quickly access data on how immunogenic and “human-like” a protein is in comparison to others.
The potential impact of this collaboration is immediately apparent to experts in the biotech industry, a multi-billion dollar global enterprise that will soon surpass small molecules as a source of new drugs to treat human diseases. “The purity of these complex genetically-engineered therapeutic agents continues to be one of the biggest challenges for the biotechnology industry,” said Greg Paquette, director of the Biotechnology and Medical Laboratory Science programs at URI.
The research team expects this tool to have significant value for protein engineers looking to assess risks quickly and accurately.
EpiVax plans to develop the tool further to include other common production host cell lines. The current beta version of CHOPPI is available for academic users through iCubed’s website http://www.immunome.org/choppi/. CHOPPI is available for commercial use through EpiVax http://www.EpiVax.com/choppi.