The FDA suspended a clinical trial for a Factor IX protein in 2012 but a new web-based tool may help avoid that very issue in the future. In a collaboration between Dartmouth, University of Rhode Island and EpiVax Inc., researchers have developed a tool that will help manufacturers of protein-based therapeutics improve the safety of their manufacturing process. The tool, known as CHOPPI (CHO Protein Predicted Immunogenicity), predicts the product associated impurities will trigger an adverse response in patients.
Protein therapeutics are frequently produced in host cells such as CHO cells. These hot cell proteins have been known to contaminate and ultimately damage the final product. The immunogenicity of a CHO protein is generally low based on the fact that it’s very similar to a human protein. However, some believe that “any protein is potentially immunogenic”. The tool is expected to help predict these immune responses of these host cell proteins and ultimately aid protein engineers in accurately assessing the purity of the final product.
Said Greg Paquette, Director of the Biotechnology and Medical Laboratory Science Programs, at URI, "The purity of these complex genetically-engineered therapeutic agents continues to be one of the biggest challenges for the biotechnology industry.”
More details can be found on this new tool in this Biotechnology and Bioengineering report.
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