Bioanalysis

Evotec and its subsidiaries have a breadth of experience in bioanalysis for small molecules and bio-therapeutics of any size: peptides, recombinant proteins, monoclonal antibodies, oligonucleotides, as well as anti-drug antibodies, vaccines, cell therapies and gene therapies, for non-clinical and clinical sample analysis. The scientific experience, capacity and application of the state-of-the-art bioanalytical equipment provide fast turnaround that will help to arrive at “go/no-go” decisions faster. Our bioanalysis service is part of both standalone services as well as fully-integrated packages.

We can offer both non-GLP and GLP bioanalytical services with validated methods appropriate for regulatory submissions.

Our bioanalytical laboratories in Verona are GLP accredited by the Italian Ministry of Health and are authorized by AIFA (Italian Drug Agency) to perform analysis supporting clinical trials, including Phase I studies in healthy volunteers and patients.

Our Bioanalytical group also includes clinical pathology laboratory activities in order to support preclinical and clinical studies.

The bioanalytical capabilities can serve also as part of an INDiGO program which allow all aspects of drug development in a single site and are designed to de-risk and accelerate IND-enabling programs.

The bioanalytical facility offers the capability to store up to 290,000 biological samples in dedicated -20 and -80ºC freezers connected with a validated temperature monitoring system.

Reliable and robust bioanalytical methods are critical for quantitative analysis. Developing a bioanalytical method requires an understanding of structural and physicochemical properties of the test compound in order to optimise the method and identify the most favorable chromatographic methods and sample preparation techniques.

Our advanced bioanalytical method development service is used to demonstrate that a particular bioanalytical method used for quantitative measurement of analytes in a given biological matrix is reliable and reproducible for the intended analytical application. The fundamental parameters assessed include accuracy and precision, linearity and sensitivity, selectivity, recovery and stability.

For routine screening of compounds, we employ a number of generic LC-MS/MS optimization and analysis procedures which guarantee high quality optimization for over 99% of the compounds screened.

• Method development and transfer
• Method qualification
• Method transfers of existing validated methods
• Method validation
• Cross-validation of method performance against existing laboratories
• Dose-formulation analysis
• Non-GLP and GLP analysis in support of preclinical studies
• TK elaborations
• GCP sample analysis in support of Phase I-IV, drug-drug interaction, bioequivalence studies
• Preparation of PBMCs
• Analysis of biomarkers
• Immunogenicity strategy including ADA (screening and confirmatory) and neutralizing assays
• Support to ADME studies (see. Discovery Bioanalysis)
• Clinical sample management including kit preparation for clinical trials
• Clinical pathology laboratory staff has extensive knowledge of animal hematology, coagulation, clinical biochemistry and urinalysis

• Chromatography
• Mass spectrometry including high-resolution MS
• Metabolite Profiling
• Dried blood spot analysis
• Microsampling analysis
• Analysis of chiral compounds
• Analysis in a wide range of biological matrices like plasma, urine, serum, whole blood, CSF, PBMC and any kind of animal tissues
• Immunochemistry
• Cell-based assays
• Flow cytometry
• Molecular biology

• Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
• Micro-Liquid chromatography-tandem mass spectrometry (microLC-MS/MS)
• Liquid chromatography-high-resolution mass spectrometry (LC-MS, HRMS)
• Liquid chromatography (HPLC, UHPLC) with UV, DAD)

• ELISA/EIA
• Meso Scale Discovery (MSD)
• Single Molecule Counting Ultrasensitive Platform (SMCxPRO)
• Single Molecule Counting High sensitivity Biomarkers Platform (Quanterix SR-X)
• Hybridization assays
• Luminex^® technologies
• ELISpot assay
• Multiplex assay
• Flow cytometry
• Fluorescence immunoassay (FIA)
• qPCR

• ADVIA 2120i Siemens (haematology)
• COBAS6000 Roche (clinical chemistry)
• Stago STA Compact (coagulation)
• Clinitek Siemens (urine analysis)