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.
Host cell protein analysis categories
Test new limits of detection, characterization, and quantitation of host cell proteins at trace PPM levels in complex biopharmaceutical drugs. The latest in the Tribrid product line, the Thermo Scientific Orbitrap Fusion Lumos Tribrid Mass Spectrometer features enhanced sensitivity resulting in to perform more comprehensive sample analyses faster and with better accuracy; ensurung the quality and safety of your biotherapeutic protein.
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.
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.