PROVIDENCE, R.I., July 8, 2014 /PRNewswire/ -- A Public-private partnership resulted in the development of a new web-based tool that will 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. Greg Paquette, Director of the Biotechnology and Medical Laboratory Science Programs, at URI, stated; "The purity of these complex genetically-engineered therapeutic agents continues to be one of the biggest challenges 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 firstname.lastname@example.org
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