You might have an annoying allergy or know a close friend with one. The reason is often unknown, but small, foreign substances in presumably all medicine are now suspected to be the cause.
You probably know this; you should ideally include protein in your diet every day. This is because of the various functions which proteins govern and perform every day in all living organisms.
However, you might not know that an increasing number of medicine products use protein as the active substance. The protein is often specialized to target a specific area of the body and thus treat a certain disease or condition.
Unluckily, there is a small down-side associated with the production of the specialized protein-containing drugs. Small side-products are co-created in the production and end up in the final product. They are suspected to alter the medicinal protein’s function in the body, the durability of the drug and possibly cause allergic reactions over time.
Unwanted: Host cell proteins
The small side-products are also proteins, the so-called Host Cell Proteins (HCPs). As the name implies, they come from a host cell. A host cell is a system that can be manipulated to produce a specific product, such as a specialized protein. Commonly used host cells are bacteria or yeast, which have a simple structure compared to humans. This allows for a faster and easier production of the desired protein.
When the protein has been produced, the target is to remove as many impurities (including HCPs) as possible – for cleaner and more effective medicine. As mentioned, HCPs might decrease the impact of the protein, thus requiring a higher medicine intake. Furthermore, there is a prominent risk of HCPs causing allergic reactions by activating the immune system. This is due to their foreign nature, which forces the automated immune cells to act. Patients may experience this as a range of uncomfortable symptoms and the risk of the long-term effects is clearly higher for patients on medicine taken daily.
The problem and, luckily, also the solution
Of course, there is a bunch of requirements for new drugs entering the market, concerning drug content and patient safety. Everything must be documented for governmental approval.
But are the requirements strict enough? The approved methods for HCP documentation are neither sensitive, reproducible or fast enough. It is apparent that the approaches should reach another level.
Recently, mass spectrometry (MS) has been named the next big thing for host cell protein detection. The method is already applied to determine the content of food products, analyse the nutrition level based on e.g. blood samples, support forensic work etc.
In relation to laboratory work and analysis of HCP levels, the MS method is highly interesting. MS is highly sensitive and can detect individual HCPs and their precise amount. It even removes the need for laboratory animals – as required for the current HCP analysis method. It is believed that the method will lead to cheaper, cleaner and safer medicine, where the patient does not have to worry about possible allergic reactions and worse symptoms.