Host Cell Protein Detection Kits

https://www.elisakit.cc/products/host-cell-protein-elisa-kits/

Examples of HCP Related Issues with Biologics
In 2006, an immunogenicity issue occurred to Omnitrope (rHGH biosimilar), the cause of which was linked to excess host cell protein contamination.

In 2008, Alpheon and Roferon-A finished products were also investigated for the composition of the different impurities that were not fully studied.

In 2013, IB1001 was a recombinant product for treatment and prevention, the clinical studies of which were on clinical hold due to a higher-than-expected rate of host cell antibody development in people treated with IB001.

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