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Most biopharmaceuticals use host cells to express target proteins through DNA recombinant technology. 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 laws and regulations of various countries have corresponding requirements for HCP residue detection. ELISA method is the method recommended by pharmacopoeias of various countries. The US FDA recommends that the content should be less than 100 ppm, and the Chinese Pharmacopoeia's recombinant vaccine monograph recommends that CHO cell HCP should be less than 0.05%.

Packing Specifications:

The packaging specifications of the CHO host cell protein detection kit are as follows:

Detection principle:

The ELISA method and horseradish peroxidase catalyze TMB substrate to produce a color reaction, and the value is read by an enzyme reader at a wavelength of 450nm. The CHO standard protein standard curve is used to quantitatively analyze the content of HCP in the sample to be tested.

Features:

This kit contains all the components required for CHO host cell protein (HCP) detection. It can quickly and efficiently detect HCP residues in biological products produced by Chinese hamster ovary cells (CHO), with high antibody coverage, good linearity, and high sensitivity. The CHO HCP antibody in the kit is rabbit antibody and is purified by a special process. The 2D/WB antibody coverage is 80%. This kit is a general kit that can be used for process development and quality control of most CHO cell expression systems.

Special tips:

1. This test kit is only for professional technicians with common sense of laboratory safety. Please read the product instructions carefully before using this product.

2. The stop reagent is acidic. Special care should be taken during operation to prevent contact with skin and eyes.

3. Streptavidin-HRP must be stored at -20℃ for long term upon receipt, and other reagents must be stored at 2~8℃.