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).
Choose an instrument for host cell protein analysis
| 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 |
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.
Host Cell Protein (HCP) Profiling and Quantitation in Gene Therapy Products with the Orbitrap Astral Mass Spectrometer
Learn how you can achieve confident, sensitive and reproducible AAVHCP identification and sub-ppm quantification using a novel HRAM platform with increased throughput.
Spend less time on sample prep, and more on proteomics research
The Thermo Scientific AccelerOme automated sample preparation platform, with factory-supplied reagents and kits, intuitive software and a unique experimental design experience transforms proteomics sample preparation.