Secure batch compliance with ultra-sensitive, validated process impurity analysis
The Challenge of Process-Related Impurities
During the production of biomolecules (monoclonal antibodies, vaccines, viral vectors), the introduction of auxiliary reagents is essential to optimize cell culture and downstream processing (downstream). However, these substances must be drastically removed from the final product:
Bovine Serum Albumin (BSA): used as a cell growth supplement, it presents major risks of immunogenicity and transmission of pathogens to humans.
Benzonase: introduced to digest residual host cell DNA, this active enzyme must not be injected into the patient, as it could cause inflammatory reactions or degrade therapeutic nucleic acids (in the case of gene therapies).
Regulatory authorities (EMA, FDA, ICH Q6B) require rigorous proof of the clearance of these reagents. Their final concentrations must often be reduced to undetectable traces (on the order of ng/mL or ppm).
Our Analytical Solutions for the Quantification of Residual Reagents (BSA, Benzonase)
High-Resolution Mass Spectrometry (LC-HRMS - Orbitrap / Q-TOF)
Thanks to High-Resolution Mass Spectrometry analysis (LC-HRMS - Orbitrap / Q-TOF) and a targeted proteomic approach (peptide digestion and screening of signature peptides), we quantify BSA and Benzonase with absolute specificity, even within ultra-concentrated protein matrices.
Size Exclusion Chromatography (SEC)
Analysis by GPC/SEC is a powerful orthogonal method that allows us to separate and monitor the purity profile of your biomolecule by isolating the fractions corresponding to the molecular weights of BSA and residual enzymes.
Why Choose FILAB for the Quantification of Residual Reagents (BSA, Benzonase)
Entrusting your analyses to the FILAB laboratory allows you to benefit from state-of-the-art equipment without investing in heavy in-house development.
Compliance with international guidelines: our analyses align with the requirements of the European (Ph. Eur.) and American (USP) pharmacopoeias, as well as the ICH Q6B guidelines.
Expert scientists: a team of PhD researchers and engineers specialized in molecular biology and biopharmaceutical method validation.
Traceability and data integrity: complete, detailed, and structured analytical reports ready to be directly integrated into your CTD registration files.
Flexible volumes: from one-off testing during the R&D phase to monitoring pre-clinical and clinical production batches.
Our Services Dedicated to Biopharmaceutical Product Analysis
Identity and structure of biomolecules: primary sequence (peptide mapping), de novo sequencing
Secondary and tertiary structure analysis: thermal stability, circular dichroism (CD), UV/visible profiles and analysis by FTIR
Analysis and localization of disulfide bridges
Our FAQ
To get a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (type of material, analysis requested, any standard, urgency, number of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your constraints and industrial urgencies.
Thanks to the sensitivity of our Orbitrap and Q-TOF systems and our optimized extraction protocols, we achieve quantification limits on the order of parts per million (ppm), or even ppb (parts per billion), depending on the nature of your matrix. This fully meets the safety requirements of regulatory agencies (EMA, FDA).
LC-MS/MS quantifies the total (structural) protein amount of residual Benzonase. For regulatory authorities, proving the physical absence of the enzymatic protein is the most robust safety evidence. If the enzyme is absent or present below the detection limit, the risk of residual activity is mathematically ruled out.
Yes. All our process impurity quantification methods are developed, qualified, and validated in strict compliance with international ICH Q2(R1) guidelines. For each project, we assess the specificity, linearity, accuracy, precision (repeatability/reproducibility), and robustness of the method in your specific matrix.
