Did you know this about your medicine?
Medicine is an invaluable necessity for our well-being today. Even though the different products improve our health, they could be even better.
Most medicinal products are made up of proteins
Yes, this is indeed true. Protein is more than an essential part of your plate every day or a selling point on dairy products in the supermarket. You cannot live without them, since they are needed for all reactions in your body. The list of functions is indeed endless. Therefore, it is interesting to look at the use of specialized proteins for treatment of various diseases.
Proteins can be designed and thus produced by using simple organisms, such as bacteria and yeast, the so-called host cells. Their simple nature and short generation time make it possible for scientists to control them and produce specific proteins in high amounts within a short time.
Unfortunately, there is a small hiccup… During the protein production, small molecules piggy-back on the desired protein and thus end up in the patient’s body at intake. These are called Host Cell Proteins (HCPs) and can lead to allergic reactions, or worse symptoms, if not removed during the medicine production.
The threat you should be aware of
But why is this even an issue? Shouldn’t FDA prevent this? The requirements for drug approval are relatively tough. Comprehensive analyses are always conducted before a drug is released to patient use, but they are simply not good enough. The FDA’s approved method for host cell protein detection relies on laboratory animals and their blood. Even though it takes advantage of antibodies, which in the human body performs targeted attacks on foreign particles, the method (called ELISA) is unprecise, hard to reproduce, and unreliable.
The problem with an improper analysis of the HCPs in medicine is that these molecules might cause severe symptoms in several years after medicine intake. It is impossible to know what HCPs can do to the body, especially since they will get the immune system’s attention, as a result of their foreign nature. Therefore, they should be completely removed before the protein medicine reaches the patient.
Should you panic?
Luckily for FDA (and all patients) a new method have been established to achieve the needed overview of all HCPs in the medicine. It is based on a technique called mass spectrometry (MS) and it has been around for a while. Due to its ability to analyze the protein content in various samples, it is perfectly suited for HCP analysis.
With this method, all individual HCPs are detected, their amount is determined, and it is much easier for the medicine producer to remove them. Thus, the medicine will become safer for the patient and ensure that there is no risk of developing allergies from HCPs in the drug product.