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).

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Choose an instrument for host cell protein analysis

 Orbitrap Exploris 480 Mass SpectrometerOrbitrap Exploris 240 Mass Spectrometer
 Orbitrap Exploris 480 Mass SpectrometerOrbitrap Exploris 240 Mass Spectrometer
AdvantagesExtraordinary simplified within a compact footprint where next level exploration delivers quantifiable accuracy and the selectivity required to comprehensively identify and quantify host cell protein contaminants.Realize complete BioPharma characterization and identify, quantify and confirm more host cell proteins rapidly and with confidence.
Resolving power480,000 at m/z 195Up to 240,000 at m/z 200
Scan speedUp to 40Hz22Hz
Mass range40 to 6,000 m/z (up to 8,000 m/z with the BioPharma option)4 to 8,000 m/z
Dynamic range>5000:1>5000:1
Mass accuracyInternal <1 ppm RMS; External: <3 ppm RMSInternal <1 ppm RMS; External: <3 ppm RMS