Bioanalysis
 

 

Evotec has a breadth of experience in regulated 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 Bioanalytical group includes also clinical pathology laboratory activities in order to support pre-clinical studies. 

Bioanalytical validations are performed according to EMA/FDA guidelines and the analyses are performed in compliance with GLP or GCP regulations. 

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.

The scientific experience, integrated services, 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. 

The bioanalytical capabilities can serve also as part of an INDiGO programme,  Evotec’s solution designed to de-risk and accelerate IND-enabling programmes.

The bioanalytical facility offers the capability to store up to 280,000 biological samples in dedicated -20 and -80ºC freezers connected with a validated temperature monitoring system.

Our range of services and capabilities include:

  • 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 pre-clinical 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 neutralising assays
  • Support to ADME studies 
  • Clinical sample management including kit preparation for clinical trials
  • Clinical pathology laboratory staff has extensive knowledge of animal hematology, coagulation, clinical biochemistry and urinalysis

Our experience spans

  • Chromatography 
  • Mass spectrometry including high-resolution MS
  • 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 

Mass spectrometry platforms

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

 

 

Ligand Binding Assay Platforms

  • ELISA/EIA
  • Meso Scale Discovery (MSD)
  • Single Molecule Counting Ultrasensitive Platform (SMCxPRO)
  • Hybridisation assays
  • Luminex® technologies
  • ELISpot assay
  • Multiplex assay 
  • Flow cytometry
  • Fluorescence immunoassay (FIA)
  • qPCR

Clinical Pathology platforms

  • ADVIA 120 (haematology)
  • COBAS6000 (clinical chemistry)
  • STA Compact (coagulation)
  • Clinitek Atlas (urine analysis)

Bioanalysis is part of fully-integrated packages, including all aspects of drug development in a single site (INDiGO). Evotec’s Bioanalytical Department is part of EBF (European Bioanalytical Forum).

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Our INDiGO services

Contact us

Evotec

Business Development

T +44.(0)1235.86 15 61 F +44.(0)1235.86 31 39 vCard
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