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
 |
Hamster ELISA Kits | Hamster ELISA Kits A hamster is also known as suslik, which is an animal domesticated by wild animals and entered the laboratory. There are 8 kind... |
 |
BlueGene Biotech Fish Cyclic Adenosine Monophosphate ELISA kit | E17C0027 Fish Cyclic Adenosine Monophosphate ELISA kit Fish ELISAkit is suitable for the detection of samples from fish species. Cyclic Adenosin... |
 |
Human Collagen, Type I, Alpha 1 ELISA kit | NE01C1899 Human Collagen, Type I, collagen 1 elisakit Human Collagen, type I, collagen type i alpha 1kit is suitable for the detection of sample... |
 |
Human Asymmetric Dimethylaoyoinine ELISA kit | E01A0035 Human Asymmetric Dimethylaoyoinine ELISA kit Human Asymmetric Dimethylaoyoinine ADMA ELISAkit is suitable for the detection of samples ... |
 |
BlueGene Biotech | Bovine Carnitine Palmitoyltransferase I ELISA kit Metabolism E11C0055 Bovine Carnitine Palmitoyltransferase IELISA kit Bovine Carnitine Palmit... |
Same products
 |
KYODO YUSHI PAREMAX SUPER 400G High Temperature Grease | 卖方: 广东聚广恒自动化设备有限公司 | Ball bearing grease. Excellent in low noise property and usable over a wide temperature range.Rar... |
 |
Mobil CHASSIS GREASE LBZ 16KG Exhibits Excellent Flow even at very low tempe Eatures and in Long Pipelines | 卖方: 广东聚广恒自动化设备有限公司 | Mobil Chassis Grease LBZ ist ein Fließfett auf der Basis synthetischer Grundöle in der... |
 |
Mobil Velocite Oil No 6 Spindle Oil 16KG | 卖方: 广东聚广恒自动化设备有限公司 | KLUBER MOLYKOTE EM-50L 1KG KLUBER MICROLUBE GBU-Y 131 1KG KLUBER CENTOPLEX GLP 500 1KG Kluber... |
 |
Low density Oxidized polyethylene wax OPE WAX | 卖方: Syntop chemical Co.,Ltd. | Oxidized polyethylene wax (OPE wax) is an excellent new type of polar wax with special properties... |
 |
KLUBERSYNTH UH1 14-222 1KG Food Machinery Bearing Extreme Pressure Grease | 卖方: 广东聚广恒自动化设备有限公司 | a synthetic lubricating grease for universal application in the food-processing and pharmaceutica... |
