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 drug safety and efficacy problems. HCPs can reduce drug efficacy, trigger immunologic responses in patients, or the biological activity of an HCP may cause an adverse event.
CRO with Integrated HCP Analysis Services
Prolytix offers unique and comprehensive bioanalytical services to the biopharmaceutical industry to solve HCP challenges. Using ELISA and high-resolution mass spectrometry (HRMS), 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 is during process development, as building in quality from the start is a much better approach than fixing problems in the late stages of development.
Applicable Drug Substances for HCP Testing Services
- Monoclonal antibodies (mAbs)
- Recombinant proteins: fusion proteins, chimeras, active enzymes, zymogens, etc.
- Gene therapies
- Vaccines
HCP Methods
There is no such thing as the “perfect HCP detection method.” Each has strengths and weaknesses, so a combined approach is recommended. The core methods used today are HCP ELISA and HRMS.
HCP ELISA
The HCP ELISA test is both the workhorse and gold standard in biopharma. Briefly, HCPs from a null cell line are injected into animals (goat, sheep, rabbit, etc.), and the antibodies generated against those HCPs are collected, purified, and used in the ELISA. By using antigen-antibody interactions between the ELISA reactive components and the actual HCPs, ELISA tests can detect the presence of HCPs at very low concentrations. The HCP ELISA test is a reliable tool for analyzing protein samples because it can detect variations of protein integrity related to manufacturing interference.
The HCP ELISA has two advantages:
- high throughput
- the result is a simple single number that is conceptually easy (on the surface) to remember and use to track purification of the product.
HCP High-Resolution Mass Spectrometry Analysis
Prolytix uses high-resolution mass spectrometry (HRMS) to provide phase-appropriate methods for HCP analysis of biotherapeutics from early-phase development through GMP release testing. Using a consultative approach, we identify and mitigate HCPs to help ensure product purity and safety.
Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs
Customer-Oriented Legacy of Prolytix’s HCP Projects
Many of our HCP projects at Prolytix require creative problem-solving. We specialize in working with startup companies that do not have the resources for HCP ELISA and mass spectrometry analysis. We also work with companies using a CDMO to develop the process, but the CDMO does not have the bandwidth to solve a particularly sticky HCP problem. Additionally, we’ve worked with companies that suddenly have an HCP problem. Contact us to see how our advanced bioanalytical services can help you quickly overcome your HCP problems and start your clinical trials with a high-quality product.