HCP Analysis: ensuring the Purity and Safety of Biologics
Ensuring the purity of finished products is essential to guarantee safety across all applications, from monoclonal antibodies (mAbs) and recombinant proteins to vaccines.
During production, host cell lines (such as CHO, E. coli, HEK, or yeast) inevitably release their own proteins, known as Host Cell Proteins (HCPs). Even at trace levels (ppm), these process-related impurities can present significant risks and must be rigorously monitored.
FILAB supports pharmaceutical companies by offering complete HCP characterization strategies, compliant with the strict requirements of regulatory agencies (ICH Q6B)
Is HCP testing essential for your process validation?
HCP Analysis
Monitor Clearance: demonstrate the efficiency of your purification steps (Chromatography, Filtration)
Investigate failures (Troubleshooting): understand why a specific batch shows abnormal impurity levels
Ensure reproducibility: prove batch-to-batch consistency to health authorities
OUR SERVICES DEDICATED TO BIOPHARMACEUTICAL ANALYSIS
Residual DNA analysis
Study of solvent residues and culture medium (cell culture): amino acid analysis...
Why choose FILAB ?
- Dual competence: Chemistry / Materials
- State-of-the-Art Analytical facility: A 5200m² laboratory
- Problem solving: We don't just provide a number; we investigate the root causes of contamination
- R&D support: Dedicated teams for method transfer and validation according to ICH Q2
Our FAQ
This depends on the protein concentration and the chosen method. Generally, a few milliliters or milligrams of active substance are sufficient. Contact our technical sales team for a precise feasibility study.
To get a quote, you can contact our team via our contact form, by phone, or by email.
Simply send us your requirements (material type, desired analysis, specific standards, urgency, number of samples, etc.). We will then send you a personalized technical and price proposal within 24 to 48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the project.
However, FILAB is committed to providing fast results tailored to your industrial constraints and urgent needs.