Cygnus CHO HCP Test Kit Introduction and Selection Guide

Cygnus Technologies Inc. ("Cygnus") is a US company specializing in providing professional analytical products and solutions for process development and quality management for pharmaceutical and biotechnology companies. As a recognized leader in biological contaminants, Cygnus' product line covers a wide range of HCP test kits for a variety of different hosts, Protein A test kits for different fillers, host DNA residue test kits for different experimental needs, and others. Kit for the detection of contaminant residues in biological processes, as well as proprietary antibody and kit customization services for specific samples and processes.

Among the many products of Cygnus, the most famous CHO HCP residue detection kits, since the market, this series of kits has not only been recognized by the majority of users, but also by the local drug regulatory authorities, such as the US FDA, China CFDA, Save a lot of time and money for enterprise product declarations. Currently, the Cygnus CHO HCP test kit has been developed to the third generation. For some reason, Cygnus did not stop producing the first two generations of kits while developing new kits. This has caused some users to have troubles in product selection. What is the difference and connection between these three kits? Why did the launch of the new kit not lead to the discontinuation of the boss kit? How do people who are doing HCP research for the first time choose the right kit? The following sections will compare and analyze different kits and give suggestions for selection.

F015 first generation CHO HCP detection kit. F015 is the first CHO HCP detection kit developed by Cygnus 12 years ago. After the eluted CHO cells are gently lysed, the lysate is used as an immunogen and used for affinity purification of antibodies and kit standard establishment. . This gentle cleavage process produces a series of HCPs that are very similar to HCP in cell culture media when harvesting products.

CM015 second generation CHO HCP detection kit. Two years after the F015 kit was launched, Cygnus introduced the second generation CM015 for CHO HCP testing. The second generation kit uses conditioned media for kit development. Since most of the products expressed by CHO cells are secreted into conditioned medium, antibodies or kits developed in this medium are more Cell lysates are more specific.

F550 third generation CHO HCP detection kit. To this day, Cygnus' third-generation F550 CHO HCP test kit has been recognized by users worldwide. Similar to CM015, F550 also uses conditioned medium for antibody production. However, the Cygnus R&D team used the latest technology to screen out a new conditioned medium. The HCP validation results from this medium show that these HCPs are more widely found in most CHO-expressed products. Therefore, for most samples, the F550 is currently a kit that can react more widely with different samples and provide more accurate results.

Selection of CHO HCP test kits. For a given product or sample type, no one can predict which kit is best for the first time without prior verification. Because the production of F550 antibodies and the development of kits use the most advanced technology, and antibodies can react more widely to most samples, it is recommended that new users first test the kit. Whether the chosen method is applicable requires the user to verify from the aspects of sensitivity, accuracy and specificity. First, the specificity of the kit is verified, ie the additive, buffered salt, pH, or product protein itself in the sample does not cross-react with the antibody in the kit. Otherwise, this increase in non-specific binding will overestimate the actual HCP content. After specificity is determined, the user should confirm that there are no substances in the sample that can inhibit true HCP detection. This can be verified by spiked recovery experiments on the sample to be tested. To further prove this, a linear dilution experiment was also performed to demonstrate whether the sample contained an excessive amount of HCP that normally appeared in the upstream of purification. The combination of the above verification results can provide a preliminary indication of which kit is more suitable for a particular sample.

The above is a description and selection of different CHO HCP test kits for Cygnus. I hope that readers will benefit from the selection of the most suitable test method for their own samples. Beijing Ximeijie Technology Co., Ltd. (hereinafter referred to as “Ximeijie”) acts as the agent of Cygnus in China, and has established long-term and stable cooperative relations with many well-known domestic pharmaceutical companies and CRO/CMO enterprises. Over the years, Ximeijie's products and services have helped many companies accelerate the R&D phase, improve drug quality, purity and safety, accelerate the optimization of research and development processes, reduce time-to-market and reduce QC costs. If your product involves a special sample or expression system, ximeijie can also customize the solution and verification service for your product. For more information, please call Ximeijie 010-88597838 to discuss.