HCPs are endogenous, process-related impurities derived from expression systems during biotherapeutic production. Even at trace levels (0.1–100 ppm), these impurities have the potential to produce unwanted immunogenic response in patients, or can reduce the safety, efficacy or stability of the therapeutic. For these reasons, regulatory agencies require that HCPs be identified, quantified, and controlled prior to drug approval.
Partner with Waters to improve your HCP identification and quantification with a wide dynamic range, high resolution LC-MS workflows. Confidently identify and monitor HCP variation from many manufacturing and purification conditions, ensuring patient safety while meeting regulatory compliance requirements.
Combine novel cyclic ion mobility separation with state-of-the-art high-performance, time-of-flight mass spectrometry with the SELECT SERIES Cyclic IMS, enabling researchers to reliably identify and monitor HCPs at low levels.
Confidently identify and monitor HCPs during product development with the SYNAPT XS that combines flexible ion mobility separation with high-performance, time-of-flight mass spectrometry.
Accelerate routine HCP identification with the Xevo G3 QTof high-performance HRMS benchtop system that delivers accurate qualitative and quantitative results.
Enable routine HCP monitoring for process development with Waters BioAccord LC-MS System that includes high-resolution MS and waters_connect software for compliance-ready data analysis and reporting.
HCP monitoring assay for process development shows summary plots of spiked peptides, all detected with similar detection limits to process development discovery assay.
Extracted mass chromatograms for two low abundance HCP peptides identified in NIST mAb digest using process development discovery HCP assay.
