Not many people know this, but there are certain particles from bacteria in modern medicine. However, this part of wide-spread medicine, could be removed from the product with a brand-new technique.
Besides the active ingredient, which treats the disease or condition, there is other content in medicine. Inactive ingredients, such as binding materials, preservatives, dyes and flavouring substances, are added to help the active ingredient reach and treat its target part of the body.
However, there is also content that is not purposely included in the final product – impurities that arise during the production of the active ingredient. They are not added to the product like the inactive ingredients and do not help the active ingredient perform its function. On the contrary, they may even limit the functionality of the active ingredient.
But what is the nature of the key impurities? Let’s elaborate on this subject.
Medicine contain remains of bacteria strains or other non-human organisms
To produce custom-made active ingredients, a simple organism is often used as the “host”. This could be a bacteria strain, which enables fast production at low cost. Its genetics can be manipulated to produce a desired protein (active ingredient) with a form and function to treat a human disease.
When the desired protein is produced by the host, other proteins, so-called host cell proteins, may follow along. Therefore, these host cell proteins must be separated from the other proteins through several cleaning steps.
Unfortunately, it is difficult to get rid of all the host cell proteins without harming the desired protein. A host cell protein assay can be used to determine the remaining amount of host cell proteins, but today’s most applied analysis it not that good, to be honest. The method called ELISA only gives you the total amount of all host cell protein – and you often won’t see the same result two times in a row.
Are impurities in medicine harmful for patients?
The long-term effect of impurities in your medicine is unknown. But since the proteins come from bacteria, they are foreign to your body and could cause an immune reaction – either within short or long time. The more times you are exposed to them, the higher the risk of allergies or even worse side effects. Also, host cell proteins may affect the function of the active ingredient and decrease the durability of the medicine product. But what is the solution? Stay calm, a new technique can solve all of this.
Cleaner medicine can me made – if FDA demands better measuring techniques
A new host cell protein assay has seen the light and can detect all unwanted impurities, before the drug is released to patients. It is based on a technique called mass spectrometry and is already used for e.g. forensic analyses, metabolic studies and food content overviews.
The method can tell the medicine manufacturer about the individual host cell proteins found in the product, their chemical properties and the exact amount. From there, it is relatively easy to remove them and increase patient safety. Surprisingly, FDA (USA) and EMA (Europe) do not require mass spectrometry and still accept the unprecise ELISA measurement.
Cross your fingers and hope that this changes within the nearest the future.