Preclinical & Clinical Analytics
Our bioanalytics team will make sure that all methods used in your studies are well-adapted to the tested products and that analyses are performed efficiently, while maintaining high-quality of the data. By contracting Mabion you get an all-embracing partner capable of running all basic bioanalitycal assessments including PK, PD and immunogenicity.
- One of the many services offered by Mabion is pre-clinical and clinical analytics, which covers the development, validation and transfer of bioanalytical methods as well as analysis of pharmacokinetics, pharmacodynamics and immunogenicity of biologics.
- Mabion possesses dedicated GLP-certified laboratories with first-class equipment that can work in parallel to provide high-throughput analysis of samples originating from both pre-clinical and clinical studies. We have developed a set of bioanalytical methods that can be easily adapted to different classes of biologic medications and study-specific conditions. Our bioanalytical laboratory has already processed thousands of samples from clinical trials performed in different indications.
- Pharmacokinetic analysis of monoclonal antibodies and other biologics is performed using highly efficient and fully-automated GyrolabTM Platform. Compared to the classical assays, it allows to obtain higher quality data, while substantially reducing the time of analysis.
- Pharmacodynamics is assessed using the flow cytometry and immunoassay platforms. The selected methods allow us to accelerate, standardize and achieve better control of the performed tests.
- Immunogenicity assessment covers all required analytical stages: Screening, Confirmation and Titer assays followed by the determination of neutralizing antibodies using NAb assays reflecting the mode of action of the drug, including already developed and validated ADCC assay.
Evaluation of pharmacokinetics of monoclonal antibodies and other biologics within pre-clinical and Phase I-III clinical studies. Analysis is performed with the use of high-throughput Gyrolab xPloreTM or ELISA platform.
The use of this fully-automated platform significantly increases the quality of the obtained data while reducing the analysis time compared to the classical assays. The assay features:
- Automated nanoliter-scale immunoassay generating top quality data with high throughput
- Sensitive, precise and accurate immunoassays with high selectivity/specificity and no “carry over” effect (based on validation data)
- High quality in-study data: repeatability below 10% CV for 95% of reported results and incurred samples reproducibility passed for >99% of reanalyzed samples
- Assay are performed in compliance with the GLP regulations and in accordance with international regulatory standards (FDA, EMA, ICH)
Assessment of pharmacodynamics is performed with the use of flow cytometry (BD FACSLyric) and immunoassay platform (Gyrolab xPlore). The developed methods are appropriate for any drug (biologic or not) that works by lowering the concentration of specific cell types and proteins circulating in the blood. They can also be extended to measure the quantity of specific proteins in various body tissues and fluids.
The use of automated and standardized flow cytometry and immunoassay platforms allows us to achieve higher speed, better control and increased reproducibility of the performed tests. Exceptional results were achieved for the GLP-compliant B-cell depletion assay developed in our laboratory:
- Intra and inter-assay precision <15% of CV
- Accuracy (comparison with reference laboratory) within ± 15% Bias
- Sensitivity down to 10 B cells/µL
- Developed protocol for whole blood draw and storage: sample stability extended to 14 days at 2-8℃ and to 3 days at RT
End-to-end immunogenicity assessments performed at Mabion include anti-drug antibodies (ADAs) testing with screening, confirmatory and titer assays, followed by neutralizing antibodies testing with use of competitive ligant-binding assay and bioassay formats, including ADCC cell-based assays.
Our assays are recognized for high speed, reproducibility and sensitivity of testing at a level consistent with the expectations of EU and US regulatory authorities.
- Immunobridging assay with acid dissociation performed on GyrolabTM Platform
- Innovative high throughput GyrolabTM platform
- High sensitivity (< 100ng/mL)
- High precision (CV < 15%)
- Characterization of neutralizing antibodies and titer with a highly sensitive ADCCcell–based reporter bioassay
- More reflective of the actual biological activity of neutralizing NAbs