In the biopharmaceutical industry, it has been long known that quality is not only the product; It is rooted in the process that leads to the product. Hence the need to assess quality attributes throughout the lifecycle of the product is a deep-rooted need. With the advent of technology, novel and customized approaches for assessing the process and product have been introduced that allow manufacturers to assure the safety and efficacy of their products and improve their product lifecycle.
The quality of a product can be investigated from various aspects, one of the most important aspects is host cell proteins or for short Host Cell Proteins (HCPs). HCPs are protein impurities that originate from the host that the product is expressed in and co-purify along with the target protein through the purification process.
No matter how sophisticated the purification process, there are always some HCPs that end up in the product along with the target protein. Some of these proteins are relatively harmless and are safe to be administered to humans as part of the product’s impurity profile, however, some HCPs can cause side effects in the human body and might even limit the beneficial functions of the target protein. Hence an important part of a manufacturer’s resources is allocated to HCP detection and quantitation.