CHO Host Cell Protein ELISA Kits

E.coli Host Cell Protein ELISA Kit

F.HEK293t HCP ELISA Kit

G.Pichia Yeast Host Cell Protein ELISA Kit

H.Dilution Buffer

ISO13485 for host cell protein assay kit (for Research Use Only)

Medical Device Quality Management System Certificate

Scope of approval: Research and Development and Production of Cytokine Recombinant Protein, Host Cell Protein Detection Kit (for Research Use Only)

Requirement of the Regulation (FDA, EMA, ICH)

FDA, EMA, and ICH all have precise regulations for the Host Cell Protein residues.

FDA requires that potential contaminants (including Host Cell Proteins ) introduced by the purification process should be below detectable levels using a highly sensitive method.

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.

For more information about drug residue test kit, please feel free to contact us!

BlueGene Biotech always believe that the best research and development not only comes from good products, good business and good profits but also from good customer satisfaction. We are always determined to set on long-term development.