Host Cell Protein Analysis

Identify and quantify host cell protein contaminants

Host cell proteins (HCPs) are low-level, process-related protein impurities in drug products derived from the host organism during biotherapeutic manufacturing. During expression of a recombinant protein drug, host cell systems can express many endogenous proteins. Purification of the drug from these HCP contaminants can be challenging, with low-level contamination remaining after purification. Host cell proteins (HCPs) accompanied with recombinant biotherapeutics can significantly affect drug efficacy and cause immunogenicity. Detection and quantification of residual HCPs as potential process-related impurities is critical for biopharmaceutical companies in accordance with regulatory agency guidelines (ICH Q6B).

Orbitrap-based MS analysis of HCP contaminants using the Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass Spectrometer offers a comprehensive approach to identifying and quantifying these protein contaminants. 

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Discover and monitor host cell proteins in biopharmaceuticals

Identify, quantify and confirm more host cell proteins rapidly and with confidence using the Thermo Scientific Q Exactive BioPharma Platform. This benchtop LC-MS/MS platform combines quadruple precursor ion selection with high-resolution, accurate-mass (HRAM) Orbitrap detection to deliver exceptional performance and versatility.

You now have one mass spectrometer for both peptide mapping and intact protein characterization. The Q Exactive BioPharma Platform of Orbitrap-based mass spectrometers add superior denatured and native MS intact analysis and subunit top/middle-down analysis capabilities to the most powerful benchtop peptide mapping instruments available.

When combined with Thermo Scientific BioPharma Finder software it provides a complete integrated hardware and software solution for biotherapeutic characterization.