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.
Want more on the latest in immunogenicity? Join us at Immunogenicity for Biotherapeutics
conference this October 20-22 in Boston, MA. Download the agenda to see what’s
on tap.
SAVE $100. Register here and use code XP1938BLOG.
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