Examples of HCPs that may remain in the desired pharmaceutical product include: monoclonal antibodies (mAbs), antibody-drug-conjugates (ADCs), therapeutic proteins, vaccines, and other protein-based biopharmaceuticals.
National regulatory organisations, such as the FDA and EMA provide guidelines on acceptable levels of HCPs that may remain in pharmaceutical products before they are made available to the public.
The acceptable range of HCPs in a final pharmaceutical product is large due to limitations with the detection and analytical methods that currently exist.
[5] Analysing these large varieties of protein species at very minute concentrations is difficult and requires extremely sensitive equipment which has not been fully developed yet.
[6] Enzyme linked immunosorbent assay (ELISA) is the predominant method for HCP analysis in pharmaceutical products due to its high sensitivity to proteins, which allows it to detect the low levels of HCPs in produced drugs.
[4] Even though the developmental process requires an extended period of work and several tests with animal models, analysis of HCP content in the final product can be rapidly performed and interpreted.
[4] In addition, methods such as the combination of mass spectrometry (MS) and liquid chromatography (LC-MS) have been developed to allow for more efficient and effective HCP analysis and purification.