Host Cell Protein Detection Kits
CHO Host Cell Protein ELISA Kit, G1CHO Host Cell Protein ELISA Kit, G2E. coli Host Cell Protein ELISA Kit, G1HEK 293 Host Cell Protein ELISA Kit, G1Pichia Yeast Host Cell Protein ELISA Kit, G1Dilution 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.
Requirement of the Regulation (FDA, EMA, ICH)
EMA also made a statement, Residual host cell DNA and residual host cell proteins are among the impurities to be eliminated, for HCP, whatever the product and production system, residual HCP has to be tested for on a routine basis.
Residual Host Cell Dna and Residual e coli host cell protein
ICH: For host cell proteins, a sensitive assay is utilized, and the removal of cell substrate-derived impurities such as HCP may sometimes be used to eliminate the need for establishing acceptance criteria for these impurities.
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.
BlueGene Biotechprovides e coli hcp assay, hcp assay kit,hek293 hcp assay kit, e coli hcp assay kit, pichia pastoris hcp elisa kit, host cell protein and dna, cho hcp elisa kit, etc. For more information, please feel free to contact us!
在线联系供应商
Other supplier products
 |
BlueGene Biotech Canine Caspase 3 ELISA kit | E08C0549 Canine Caspase 3 ELISAkit Canine Caspase 3 ELISA kitis suitable for the detection of samples from Canine species. Caspase 3 can also be... |
 |
BlueGene Biotech Bovine Cluster Of Differentiation 8 ELISA kit | E11C0007 Bovine Cluster Of Differentiation 8 Bluegene ELISA kit Bovine Cluster of Differentiation 8 insulin ELISAkit is suitable for the detecti... |
 |
Expression Plasmids | cre expression plasmidare a kind of double-stranded, closed-loop DNA with a size range from 1kb to more than 200kb. All kinds of antibody expressio... |
 |
Human Adenosine Triphosphate ELISA kit | E01A0038 Human Adenosine Triphosphate ELISA kit Human Adenosine Triphosphate ATP ELISAkit is suitable for the detection of samples from human sp... |
 |
Mouse ELISA Kits | Laboratory mouse makes an ideal model for human disease because the organization of their DNA and their gene expression is similar to humans. They ... |
Same products
 |
Procaine | 卖方: 862043 | CAS:59-46-1 |
 |
High Concentration Plastic Color Masterbatch Factory Direct Supply | 卖方: 861445 | We are a professional color masterbatch manufacturer with years of R&D experience in plastic ... |
 |
Acid Ink Blue G Factory | 卖方: TIANJIN LEADING IMPORT & EXPORT CO., LTD | Acid Ink Blue G Factory 【Application of Acid Ink Blue G 】 mainly used for making blue or ... |
 |
Acid Black ATT Factory | 卖方: TIANJIN LEADING IMPORT & EXPORT CO., LTD | Acid Black ATT Factory 【What’s Acid Black ATT】 is made of acid black 10B and acid o... |
 |
Acid Black 10B Factory | 卖方: TIANJIN LEADING IMPORT & EXPORT CO., LTD | Acid Black 10B Factory is mainly suitable for dyeing and printing wool ,silk and nylon fabri... |
