When pharmaceutical companies produce your medicine, especially one production part is crucial: Removal of foreign particles that have the potential to cause anaphylactic shock and even worse reactions years after medicine intake.
Most patients, and perhaps yourself, do not think or know much about medicine production. And it can seem like a real jungle out there, when you at first look into the pharmaceutical industry. Luckily, the next sections of this will introduce you to the most important step in the production processes that ultimately produce biopharmaceutical products:
- How the various drugs, essential for your health, are made using foreign cells, such as yeast and bacteria.
- How impurities that originate from the foreign cells are (partially) removed with advanced purification techniques.
- And how a brand-new method offers to revolutionize the way a drug is cleaned up before administration to patients.
Chemical vs biological medicine
Medicine can both be produced entirely chemically (without living organisms) and biologically, using living organisms. Both types have advantages that favor their use. Today, an increasing amount is produced biologically with yeast and bacteria cells. This is because these organisms are easily grown and cultivated, as well as rather simple in their structure and thus can be genetically manipulated to express proteins. The proteins are in this way customized to fit specific purposes in humans.
The impurities that piggyback on the medicine
When yeast or bacteria cells (also termed host cells) have produced the desired protein, biopharma companies use a wide range of techniques to separate it from all the other proteins expressed by the host. The other proteins are called host cell proteins (HCPs). What’s special about these proteins, since we are talking about it now? A small amount of them follow along to the final drug product by piggyback riding the desired protein. Therefore, laboratory methods are applied to filter them away. Despite several purification steps, some of them are seemingly impossible to get rid of. And do you know the scary part? Most biopharma companies only use perfunctory approaches to detect HCPs and get the full overview of their presence in the drug product. However, this is about to change due to a novel technique that quickly gains on the old (and unprecise) methods for HCP analysis.
The new technique on the block
Mass spectrometry is a method that can detect all proteins in a sample down to very low amounts. And interestingly, it does not require research animals and a bunch of expensive materials, compared to current standard methods, such as ELISA. Samples are simply put on a column that separate proteins based on their size and chemical properties. Thereafter, a mass spectrometer detects the different proteins by their individual structure and weight.
This new way of analyzing HCPs can provide the full overview of the critical impurities in a drug product. Thus, it enables biopharma companies to produce cleaner medicine and ensure patient safety.