Proteins are increasingly mentioned as crucial for a healthy body, because they have important functions in all living organisms. This is also the reason why most of new medicine today is based on proteins custom-made to target a specific process. By sending a desired protein into the body it is possible to treat various diseases and conditions. The problem with this is that during the production of the protein, side-products follow along to the final product. These unwanted proteins might affect the function of the desired protein or cause allergic reactions in the long run.
The proteins that piggyback the medicinal protein
The important class of proteins that follow the desired proteins to the final product is termed Host Cell Proteins (HCPs). They are a result of the use of a host cell for producing the desired protein. Often the host is bacteria or yeast cells, due to their simple structure and ability to be easily manipulated. The cost is low, and the production process is fast when using these hosts. It is desirable to remove as many HCPs as possible during the production – to ensure clean and effective medicine. HCPs might decrease the stability and thus durability of the drug, leading to a need for a higher intake. Additionally, they may induce an immune response in humans because of their foreign nature, which resembles dangerous organisms entering the body. This reaction leads to different symptoms and possible risks on a long-term basis in relation to development of various allergies. Literature suggests that a higher number of HCPs being introduced to the immune system leads to a higher risk of allergic reactions in years after the intake.
The (inadequate) quality check of modern medicine
Before new drugs can receive governmental approval, they need to pass a number of quality requirements. One would think that the methods for HCP analysis are comprehensive enough, but there are several issues with the popular methods used today: 1. They are not that sensitive, and 2. they cannot identify specific HCPs or HCPs found in tiny amounts. If the applied analyses were optimized or replaced entirely, it would be possible to avoid several side effects of medicine, ensure better patient treatment and reduce the prevalence of allergies both on a short-time and long-time basis.
Luckily, the solution is already ready
The method mass spectrometry (MS) could be the future substitution for the current methods used for host cell protein analysis. The most popular method that has been used for years, requires that research animals are sacrificed to produce antibodies and harvest them from their blood. By using MS no animals are needed, and the method is highly sensitive and thus accurate in the determination of HCP levels. Even the smallest HCPs can be detected and identified. The analysis is fast and is highly useful for optimization of processes during the drug production. This leads to cheaper and cleaner medicinal products with fewer impurities that could lead to allergic reactions at intake.
