Bioanalytical Services
GLP and GCP bioanalysis for small molecules, biologics, oligonucleotides and cell and gene therapies, with LC-MS/MS and ligand binding assays covering method development, validation, immunogenicity and preclinical to Phase IV sample analysis.
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Accurate drug concentration, biomarker and immunogenicity data underpin go/no-go decisions and regulatory submissions. Generating that data gets harder as pipelines move beyond small molecules to peptides, antibodies, oligonucleotides, vaccines and cell and gene therapies. Evotec's bioanalytical group covers all of these modalities for both nonclinical and clinical studies. It offers exploratory non-GLP work as well as fully validated methods suitable for regulatory filings.
Evotec’s regulated laboratories hold GLP accreditation to analyse samples from clinical trials, including Phase I studies. The site can store around 290,000 samples in monitored −20 °C and −80 °C freezers and includes an in-house clinical pathology lab. Bioanalysis is available as a standalone service or as part of an integrated development program with Evotec's preclinical, clinical and pharmacometrics teams.
Evotec’s key capabilities include:
- Bioanalytical method development, qualification, transfer and validation
- GLP and non-GLP bioanalysis for preclinical studies
- GCP sample analysis supporting clinical development
- Pharmacokinetic and toxicokinetic analysis
- Biomarker and immunogenicity testing, including anti-drug antibody assays
- LC-MS/MS, microLC-MS/MS and high-resolution mass spectrometry
- Ligand-binding and multiplex assay technologies
- Analysis of plasma, serum, whole blood, urine, CSF, PBMCs and tissue samples
- Microsampling, dried blood spot and metabolite analysis
- Clinical pathology and clinical sample management
