The utilization of biological systems in synthesizing complex therapeutic products was a significant accomplishment. During the development of the product, it’s necessary to pay great attention to define the acceptable levels of impurities resulting from this biological system. Present developments in a proteomic analysis show the diversification of this class of impurities; inevitable issue has arisen about how thorough, current approaches to measuring HCPs (Host Cell Proteins) are, as this knowledge and ability grows. The critical issue is how such a large number of protein species can be adequately measured and monitored and controlled by thousands of components to ensure safe and effective products.
The characterization of every residual HCPs is usually quite complex and challenging. One method is unlikely to be sufficient; this is particularly true in the life cycle of the product development process characterization phase. Therefore, product and process knowledge is the most important thing to achieve. This would be equivalent to the characterization of the types and masses of individual HCPs in terms of HCPs to the level that potential interactions with products or patients could be measured.
Another important method to detect coverage is affinity based on mass spectrometry also known as native coverage. To capture host cell proteins, immobilized polyclonal antibodies are used at first. Secondly, Liquid Chromatography-Mass Spectrometry (LC-MS) measurements are subjected to bound proteins for identification. The approach not only allows the assessment of ELISA reagent coverage under native conditions but also helps to understand the population of HCPs not sufficiently tracked, which in turn facilitates the improvement of ELISA reagents.
The application of an immunoassay enzyme-linked immunosorbent test (ELISA) depending on polyclonal antibodies to the host cell used to synthesize a specific therapeutic product is a smart solution. However, the measurement depends completely on the antibody serum used, which determines the sensitivity of the test and the degree of HCP coverage. It offers a summed analog value for the amount of HCP; it gives a positive value if all HCP components are considered to equal or a negative value when some components of the HCP proteome are associated with a higher risk. HCP ELISAs are not enough advanced to provide 100 percent coverage, but they are still necessary for monitoring the consistency of the process throughput of high samples and provide an appropriate means of operation in a regular quality control laboratory.