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. 

Popular host cell protein analysis products

Host cell protein analysis categories

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.

Proteome Discoverer Software
Confidently identify host cell protein contaminants

Use Thermo Scientific Proteome Discoverer software to access multiple database search algorithms (SEQUEST, ZCore, Mascot, etc.) to confidently identify production related protein impurities down to low PPM levels and validate protein IDs with false discovery rate (FDR) determination.

Use store and manage libraries for all database searching requirements, including custom libraries based on your cell lines.

Refresh your Q Exactive – Trade up to a Q Exactive HF MS or Orbitrap Fusion MS – See offer details