The medicine market has advanced extremely much over the last 10 years, with specialized drugs and better disease treatment. But foreign molecules are often found in the medicine, and they are now suspected to cause side effects over time.
Recent medicine products have become more specific toward the target disease and should (in theory) cause fewer side effects. However, it still seems that it is impossible to produce medicine without side-effects. One reason for this could be that foreign, extremely small particles, follow along with the drug itself. Recent research suggest that this is the case.
Anyway, it makes sense to get rid of medicine content not intended to be in it, doesn’t it? So let’s learn more about these small molecules.
Howe impurities end up in your medicine
Probably the most important part of medicine production is the purification process. This is when the desired drug molecule is produced, and the batch sample is cleaned for all the other content.
The drug molecule is often a custom-made protein, because proteins function great for treatment of diseases. Proteins are involved in all chemical reactions in the body and many diseases therefore arise from dysfunctional proteins. The custom-made molecules are made with e.g. bacteria host cells that ensure a fast and cheap manufacturing of proteins, with just the form and function needed.
Even though this is clever, it is here also other content shows up, besides the drug protein. Proteins from the host cell (Host Cell Proteins, HCPs) also end up in the batch and must be removed through purification processes.
One thing that is especially weird is that the most applied host cell protein assay, used to determine the amount of host cell protein in the final product is imprecise and does not provide much information. There should be a better alternative – and now, it is here.
What you need for safer medicine
A new technology has been long underway and is now ready to help all pharmaceutical companies develop or produce medicine. It is based on a method called mass spectrometry (MS), which is already widely used for forensic analyses, food production, health evaluation, etc.
Unlike the most applied method, called ELISA, MS does not require the sacrifice of laboratory animals or a long development of specific antibodies from the animal’s blood. Furthermore, MS can determine all Host Cell Protein in medicine products, even the smallest ones, and their exact amounts. This allows for a complete purification of a drug molecule, so the patient only obtain this at drug intake.
With the new technology safer medicine can be produced and thus patients do not have to worry about side effects, such as allergies, from the medicine. It is important to state that side effects can arise from other factors, but it makes sense that an introduction of foreign molecules increases the risk of long-term effects from the medicine. Also, they might affect the durability and effect of the drug molecule by harming its form and function.