Clinical and pre-clinical bioanalysis

Clinical bioanalysis services include analytical tests designed to quantitative measurement of therapeutic proteins, antibodies, and biomarkers in biological samples. Pharmacokinetics, pharmacodynamics and immunogenicity assessments are integral parts of preclinical and clinical development of biologic drugs. Unlike many other CDMOs on the market, Mabion aims to be a true end-to-end partner, offering not only broad manufacturing and quality control services, but also supporting companies in developing and running bioanalytical assays.

By partnering with Mabion you gain access to comprehensive bioanalytical services for assessing the PK, PD and immunogenicity profiles of therapeutic proteins including comparative assessment of innovative and biosimilar antibodies. Our well-qualified bioanalytical team will make sure that all developed methods are perfectly adapted to your products, delivering efficient and high-quality analyses.

In our dedicated bioanalytics laboratories we develop high throughput bioanalytical methods customized to the pharmacologic properties of a given molecule and its biological targets. Using cutting-edge equipment, such as Gyrolab xPlore, we set up specific and sensitive assays for assessing immunogenicity of innovative drugs, biosimilars and vaccines. Clinical bioanalysis must be conducted under strict regulatory compliance to ensure data integrity, traceability, and reproducibility.

All analyses are meticulously documented and summarized in an appropriately formatted report.

Whether you’re working on preclinical or clinical development, Mabion offers a full range of bioanalytical solutions to support PK, PD, and immunogenicity assessments. Our bioanalytical services include the assessment of:

Pharmacokinetics

• 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 xPlore 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.

Pharmacodynamics

• Assessment of pharmacodynamics is performed with the use of flow cytometry (BD FACSLyric) and immunoassay platform (Gyrolab xPlore). The methods developed at Mabion 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.

Immunogenicity

• 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 ligand-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.