The processes involved in producing and purifying a biopharmaceutical use many different chemicals and reagents which can result in low-levels of residual impurities in the final Active Pharmaceutical Ingredient (API). The EMA and the FDA state that these process related impurities must be monitored and identified using qualitative and quantitative assessments.
Residual levels of components from the manufacturing and purification processes (as well as any chemical manipulations that have taken place, such as PEGylation) can be problematic for several reasons. Firstly, they may provoke an adverse reaction in a patient, such as an immunologic response. They may also have an adverse effect over time on the product itself, leading to a loss of activity through breakdown or aggregation of the API, which will serve to reduce the product shelf life.
As part of an impurity assessment, it is also crucial to understand the profile of Host Cell Proteins (HCPs).These are residual proteins arising from the cell system used to produce the biopharmaceutical. The regulators require an orthogonal approach to detecting HCPs, which will often involve the use of both ELISA and Mass Spectrometric techniques.
Listen now as BioPharmaSpec's Technical Director, Dr. Richard L. Easton talks to Steven Broome, Senior Mass Spectrometrist, about using mass spectrometry for a qualitative and quantitative assessment of residual process and product related impurities.