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 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|
|Mass accuracy||Internal <1 ppm RMS; External: <3 ppm RMS||Internal <1 ppm RMS; External: <3 ppm RMS|
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.