Background:

Most biopharmaceuticals are produced by recombinant DNA technology using host cells to express target proteins. CHO cells are the most commonly used mammalian host cell line for production in the biopharmaceutical industry. In actual use, host cells themselves express a large amount of protein, so the target protein will be contaminated by protein impurities derived from host cells. The presence of these host cell proteins will not only reduce the efficacy of the drug, but also have a significant risk of causing adverse immunogenic reactions in patients. Therefore, detecting the residual HCP content in protein samples and optimizing the process to reduce HCP to an acceptable level are the key to ensuring drug safety and obtaining certification from regulatory agencies. Relevant regulations in various countries have corresponding requirements for the detection of HCP residues. The ELISA method is the method recommended by pharmacopoeias in various countries. The US FDA recommends a content of <100ppm, and the Chinese Pharmacopoeia Recombinant Vaccine Monograph recommends CHO cell HCP <0.05%.
The HCP antibody in this kit is rabbit antibody, which is purified by a special process, and the 2D/WB antibody coverage is 80%. It is also a universal kit that can be used for process development and quality control of most CHO cell expression systems.

Reagent packaging:

the Rhinogen ^® Host Cell Residual DNA Extraction Kit (Magnetic Bead Method) are as follows: