Experience a better way to identify and quantitate host cell proteins and process-related impurities
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Host cell protein (HCP) impurities pose a complex challenge. Since biopharmaceuticals are generated from biological sources, one challenge in their production is the large number of HCPs that need to be removed during the purification process. Even after multiple purification steps, some of the low-level HCPs may remain in the final products. Due to their potential to adversely impact product safety and efficacy, HCP levels must be monitored and controlled in drug products and are strictly regulated.
Traditionally, the enzyme-linked immunosorbent assay (ELISA) has been the standard method for quantifying HCPs in protein therapeutics. However, ELISA lacks the specificity and coverage to identify and quantify individual HCPs, which is an increasingly important need. Therefore, HPLC and LC/MS technologies are rapidly becoming the preferred choice for HCP analysis. The main challenge during HPLC and LC/MS analysis of HCPs was the coelution of low-abundance HCP peptides with the highly abundant peptides from the drug product. However, new HPLC, LC/MS, and column technologies are enabling better separation of peptides and ppm-level identification.
Count on innovative Agilent techniques and technologies to deliver reproducible analytical results, streamline your workflow, and increase speed, without sacrificing data quality or spectral resolution.
For Research Use Only. Not for use in diagnostic procedures.
Find on demand webinars and additional resources: Host Cell Protein Analysis Resource Page
Find additional resources about analysis for a broad range of pharmaceutical impurities and download our comprehensive impurities primer: Pharmaceutical Impurities Analysis Resource Page
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