Recombinant therapeutics, including gene and cell therapies and vaccines, are often contaminated with proteins from the host cell system from which they were produced. Called “host cell proteins” (HCPs), these process-related contaminants can co-purify along with the therapeutic protein and cause significant safety and efficacy problems.
Prolytix Offers Integrated HCP Services With a Difference
Prolytix offers a unique and comprehensive approach to biopharmaceutical industry to solve HCP challenges. Using both high-resolution mass spectrometry (HRMS) and ELISA, Prolytix provides phase-appropriate methods for HCP analysis of biotherapeutic products from early development through full cGMP release testing.
The best time to implement HCP analysis by HRMS is during process development: prevent HCP problems from happening versus trying to go back and fix them after the process has been “locked down.” At Prolytix, we have developed higher-throughput HRMS methods that can quickly and economically help companies purify their product protein.
Why HCP Testing? It’s All About Safety and Efficacy
HCPs can reduce drug efficacy (e.g., glycosidases, proteases, lipases), trigger immunologic responses in patients, or the biological activity of an HCP may cause an adverse event.
Preventing HCP Problems During Process Development
The best way to avoid HCP problems is to develop a robust process where the clearance of HCPs has been validated for each column. Mass spectrometry gives the process development team the clarity and detail needed to rationally design the purification method based on HCP identity, MW, pI, and concentration. Mass spectrometry enables the establishment of HCP clearance (on a protein-by-protein basis) at each step of the process.
At Prolytix, we have developed highly efficient LC-MS/MS workflows that can provide answers quickly and economically. We have honed these methods over the last decade, and we do not sacrifice quality and the stringency of data analysis. Our specialty is working with companies to rapidly diagnose their HCP problems so they can be solved. The days of relying on gels, blots, and ELISAs are nearing their end. Contact us to see how we can help you quickly get over your HCP problems and start your clinical trials with a high-quality product.