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 Spectrometer Orbitrap Exploris 240 Mass Spectrometer
  Orbitrap Exploris 480 Mass Spectrometer Orbitrap Exploris 240 Mass Spectrometer
Advantages Extraordinary 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 power 480,000 at m/z 195 Up to 240,000 at m/z 200
Scan speed Up to 40Hz 22Hz
Mass range 40 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 accuracy Internal <1 ppm RMS; External: <3 ppm RMS Internal <1 ppm RMS; External: <3 ppm RMS


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