Host cell protein analysis is the process of identifying and quantifying host cell proteins in biopharmaceuticals. There are different types of mass spectrometers used in the process of host cell protein analysis. However, specialists at Alphalyse use LC mass spectrometer as is it more advanced and thus the quality of results is high compared to the results obtained using other types of mass spectrometers. Host cell protein analysis always carry out identification and quantification of a single host cell protein, but experts at Alphalyse always work an extra mile to carry out quantification and identification of all host cell proteins in the provided sample at affordable prices. Host cell proteins are impurities which are mostly associated by the manufacturing process of biopharmaceuticals which at times cause instability, efficacy and generally affect the safety of the drug. As impurities, Host cell proteins may have adverse effects on the health and the body of individuals using them as the body will at all times produce antibodies to counteract the risk. To deal with host cell proteins as fast as possible there are different reagents used in the detection of the host cell proteins as soon as possible and thus dealing with them before they cause adverse effects to individuals. These reagents are generated through different processes which include;
Standard host cell protein antibody reagent generation
In the standard process of generating a host cell protein antibody, similar animals are injected using both high and low molecular weight host cell protein extract and put under observation for some time. After a while of carrying out primary boosting, the antiserum is collected from the two animals and stored separately according to the type of molecular weight host cell protein injected into the animal. In this case, the species of animals to use include rabbits, donkeys chicken, and goats among others.
Cascade host cell protein antibody generation.
Cascade is a method where animals are immunized with full host cell protein and put under primary boosting. After some time, antisera is collected from the subject animals. The developed anti-host cell protein is integrated before using them to immunoprecipitate those antigens in the antisera which are dominant. Here the antibody developed is stronger and more efficient than the one generated through the standard method because it is not selective when it comes to the molecular weight of the host cell protein. The animal used in carrying out this test include donkeys, goats, rabbits, and chicken.
Western blotting is also referred to a one dimension SDS which is analysis performed on a test subject with the aim of identifying and evaluating the reaction natural immune response when exposed to the host cell protein lysate. Western blotting allows an individual to regulate the host cell protein lysate being immunized into the test subject according to the reactions of the subject’s immune system to the host cell protein lysate. In most cases, one is advised to use several test animals of different species to evaluate the different reactions by their immune system to the host cell protein lysate.