BioPharma Product Testing

Quantitative Immunoassays Immunoassays are based on specificity and are used to quantify an analyte (bio/pharmaceutical or biomarker) in a biological matrix. These binding assays are an important tool to determine the safety and of bio/pharmaceu- ticals by assessing pharmakokinetics and . Each ligand binding must be developed using the most appropriate assay format and must be validated to ensure ro- bust data. A reliable, validated assay is vital to support critical decision making during development and clinical trials. The expertise of Eurofins BioPharma Product Testing Munich for quantitative immunoassays includes method develop- ment, assay transfer, optimization with respect to validation For the analysis of biomarkers our immunonalytics team has (including kit assays) and routine sample analysis. characterized a range of assays using the Enzyme-Linked Immunosorbent and Mesoscale Discovery (MSD) Electroche- Method Transfer miluminescence platform. These GLP/GCP compliant bio- Develop assays from scratch or adaptation of any commer- marker assays reliably detect either individual (singleplex) or cially available assay kit multiple analytes (multiplex) simultaneously and have been Method Development set up for different species. Transfer and optimization of non-validated or validated as- The following Biomarker are a representative part of our says to client specifications portfolio: Method Validation - IFN-γ, IL-10, IL-12p70, IL-13, IL-1β, IL-2, IL-4, IL-6, IL-8, Validation of analytical methods is crucial in generating TNF-α (Serum, Human) data to be used in support of regulatory submissions. Fol- - IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, KC/GRO, IL-10, IL-13, lowing GLP and the most up-to-date industry guidelines, we TNF-α (Serum, Rat) offer a fully consultative and comprehensive assay valida- tion or cross-validation service. - IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, KC/GRO, IL-10, IL-12p70, TTNF-α (Serum, Mouse) Sample Analysis - Anti-KLH IgG, anti-KLH IgM (Serum, Mouse/Rat) From preclinical trials to Phase III clinical trial projects, we are equipped to handle variable sample numbers and large - Total-IgG, Total-IgM (Serum, Rat) volumes. If desired, all our work can be performed in com- pliance with GLP/GCP to meet your specific needs. Our ligand binding assay experts are experienced in select- By selecting Eurofins BioPharma Product Testing Munich ing the most suitable assay format, including GmbH, you gain an outsourcing partner with extensive ex- perience in ligand binding assay method development, vali- • Enzyme-Linked Immunosorbent Assay dation and bioanalytical sample analysis. New projects are • Electrochemiluminescence assigned to and managed by a study director with support from a team of experienced analysts and a project manager • Time Resolved Fluorescenz ensuring high quality of data. We have extensive knowledge in establishing assays with various matrices including serum, urine, stool and tissue Any questions? Please contact us at homogenates. [email protected].

Services Chemistry/Biochemistry Molecular & With more than 25 Laboratories in 13 countries, Cell Banking Services Raw Materials Testing Facility & Process Validation Release Testing Eurofins BioPharma Product Testing is the largest GMP Manufacturing Stability Testing & Storage network of harmonized bio/pharmaceutical GMP Method Development & Validation Viral & Viral Safety Microbiology Professional Scientific Services® product testing labs worldwide. www.eurofins.com/immunoanalytics