Confirm safety and efficacy of your biologic with host cell protein (HCP) analysis from Prolytix.
Prolytix uses both high-resolution mass spectrometry (HRMS) and ELISA 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.
Verification of Commercial HCP ELISA Kits
Commercial HCP ELISA kits are frequently used during development to determine HCP levels. However, these generic kits may not always be suitable for the intended use. Prolytix can verify that the commercial kit is fit for purpose analyzing samples in parallel by HRMS and with the commercial ELISA kit. These data are essential in confirming the commercial ELISA kit is suitable for a specific manufacturing process.
Process Specific HCP ELISA Development and Validation
When HCP analysis using a commercial ELISA kit is not appropriate for determining HCPs in your product, Prolytix has years of experience developing process-specific HCP ELISAs. Fundamental to developing these methods is the production and qualification of the associated critical reagents. Prolytix combines 2D gel and western blot analysis with HRMS to fully characterize these reagents to ensure the method is robust and is suitable for the intended use.