Your medicinal product contains foreign substances along with the drug. Where do they come from, and can you get rid of them?

Much of today’s medicine is made from proteins. We call this type of medicine biopharmaceuticals. During production of specific proteins, used in biopharmaceuticals, other proteins end up in the product. These extra proteins are termed Host Cell Proteins (HCPs) and they originally come from the production host, such as bacteria or yeast cells. HCPs influence drug durability or even cause allergic reaction due to their foreign nature compared to humans.

Ways to prevent side effects from medicine

The government already deploys specific demands for HCPs in biopharmaceuticals, but are they extensive enough? Interestingly, it is uncertain if HCPs cause damage on a long-term basis. They might be associated with several of the side effects observed with marketed medicine. If we obtain more knowledge on the levels and influence of HCPs, both in present and future products, we can improve various disease treatments, prolong medicine durability and hopefully decrease side effects. Luckily, analysis of HCPs is today possible in numerous ways.

How new technologies lead to cleaner medicine

Multiple ways of analysing levels of HCPs exist, but medicine approval agencies require it to be done by the ELISA method. ELISA relies on a pool of antibodies, complimentary to different HCPs. The process sacrifices several research animals, to extract the antibodies produced in their blood.

There is a simple solution to avoid the larger number of sacrificed research animals – mass spectrometry (MS). MS is applied to determine protein levels without the need for research animals. In addition, MS provides more information than ELISA. MS is sensitive enough to detect even the smallest proteins in small amounts. The method analyses the quantity of individual proteins in a sample, and thus produces a more efficient and elaborate host cell protein analysis.