What Does HCP Refer To in Biopharmaceutical Production?
Host Cell Proteins (HCPs) refer to residual proteins derived from the host cells used during the manufacturing of biopharmaceutical products. These protein impurities originate from production hosts such as microorganisms (e.g., Escherichia coli) or mammalian cells (e.g., [CHO] cells). In biopharmaceutical processes, the therapeutic product is typically expressed in host cells, which inherently produce their own proteins. Despite extensive purification efforts during downstream processing, trace amounts of host-derived proteins often remain in the final product.
The presence of HCPs can impact both the safety and efficacy of the drug. For instance, they may provoke unwanted immune responses or compromise the purity and stability of the biotherapeutic. Consequently, regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency (EMA) mandate rigorous control and monitoring of HCP levels throughout the manufacturing process to ensure product quality and patient safety.
MtoZ Biolabs, an integrated chromatography and mass spectrometry (MS) services provider.
Related Services
How to order?
