You probably use certain medicine products. But do you know the three things that they all have in common? Especially one of them will surprise (and possibly) shock you.
1: Most products are based on proteins
Yes, you read it correctly. Protein is not just part of your diet or the often-used extra word on many food products today, directly aimed at bodybuilders, athletes etc. Proteins control and facilitate all chemical reactions in all living organisms. Therefore, they make an appropriate form of medicine, since they can be ingested and directly affect various body functions. Proteins are specialized and the function depends on the exact form.
Proteins are custom-made in the pharmaceutical industry to treat a wide range of diseases and conditions. This makes it possible to treat disease-causing cells and avoid damaging the healthy cells. You can even increase the impact of a drug and minimize the drug intake. However, during the production of the medicine, foreign particles also end up in the final product.
2: The foreign particles we do not know the (side-) effects of
You might wonder why the government is not making sure that the pharmaceutical companies remove all foreign particles from the medicine delivered to the patient. There is a clear reason for that, but first you should know more about the foreign particles.
The easiest, cheapest and fastest way to produce protein-based medicine is with a host cell, such as bacteria or yeast. Their simple nature makes it possible to manipulate them to produce specific proteins. Nevertheless, a disadvantage is that some of the host cell’s proteins follow along with the desired protein. Despite comprehensive removing steps, a number of these host cell proteins (HCPs) piggy-back ride to the final product.
The foreign nature poses as a threat to the human body and can possibly make the immune system react and attack through a typical allergic reaction. This causes discomfort for the patient. Furthermore, the particles might harm the durability or even effect of the medicine. It is thus crucial to identify the HCPs, before a complete removal can be done to protect the patient’s health.
3: Don’t worry, the necessary technology is here
Now it is time to get back to why the government cannot be sure that medicine administered to patients today, are completely risk free. The current measurement method for HCP content is based on an outdated method, called ELISA. ELISAs estimates the total amount of HCP but is not able to determine any more features than that. Also, to measure HCP by an ELISA requires blood from laboratory animals and it takes a long time to develop.
Luckily, there is a new method out there, which can determine the exact HCPs and their individual amount: Host cell protein detection by mass spectrometry. And do you know what the best thing is? It is faster, reproducible and ready to drastically decrease the risk of having unknown long-term side effects from every day used medicine.