Confirm safety and efficacy of your biologic with host cell protein (HCP) analysis from Prolytix.
Prolytix uses high-resolution mass spectrometry (HRMS) to provide phase-appropriate methods for HCP analysis of biotherapeutics from early development through GMP release testing. Using a consultative approach, we identify and mitigate HCPs to help ensure product purity and safety. We also develop assays to determine HCP antibodies in clinical samples.
Host Cell Protein Analysis By High-Resolution Mass Spectrometry
Prolytix uses HRMS analysis to identify and quantify HCPs in your process intermediates, drug substance, and drug product samples. The results of these analyses can inform decisions regarding the effectiveness of your purification process to remove HCPs.