Bioanalysis
Bioanalysis
Good Clinical Laboratory Practice (GCLP)
Reliable, high-quality laboratory data is pivotal to the success of clinical trials.
For more than 30 years, Eurofins has provided high quality, accurate results
to evaluate the effects of drug candidates across all major therapeutic areas.
Eurofins’ end-to-end laboratory testing solutions provides an array of services to ensure that any clinical trial sample is collected, transported, managed, analysed, reported and stored to meet the objectives and purpose of each study.
Our state-of-the-art bioanalytical services support clinical trials run at our own Clinical Trial Unit (CTU) or at specialized medical centres and hospitals
Full scope of laboratory services embedded within one company
Eurofins combines scientific and laboratory expertise in safety, efficacy, biomarkers, bacteriology, virology, mycology, parasitology, anatomical pathology and genomics to support your clinical trials, which results in cost optimisation of your budget and increased specimen integrity
DMPK
Eurofins is a leading supplier of bioanalysis and DMPK solutions, with cutting-edge
scientific expertise. We support clinical trials providing method development, validation, and sample analysis in all biological matrices for
both small and large molecule drug development.
We offer a comprehensive range of PK/TK, ADME, ADA, NAb, biomarker assays and sample analysis to all sponsors in the world’s pharmaceutical and biopharmaceutical landscape.
Small molecule bioanalysis
- Any biological matrix (fluids and tissues)
- Supporting screening, pre-clinical exploratory/safety and clinical studies
- Small molecules (LC-MS/MS)
- Method development, transfer and/or optimization
- Fit for purpose method qualification & validation
- More than 1000 in-house validated methods
- GLP and GcLP compliant
Large molecule bioanalysis
- Diverse biological matrix (fluids and tissues)
- Supporting early, pre-clinical exploratory/safety and clinical studies
- Large molecules - ELISA / ECL (Mesoscale)
- Method development, transfer and/or optimization
- Fit for purpose method qualification & validation
- GLP and GcLP compliant
Clinical pharmacokinetics
- Study design - From First in human to Phase III
- Food effect, elderly, hepatic/renal insufficiency, other special conditions
- In-house development and validation of bioanalytical methods
- Extensive sample-storage capacity at -20°C and -80°C
- Watson LIMS, calculation and interpretation of PK parameters (WinonLin) - statistical comparisons
- GLP/GcLP compliant
- CDISC standards
Bioequivalence
- Study design
- Pre-clinical and clinical studies
- In-house method development (LCMSMS) and validation
- Calculation of PK parameters (WinonLin), bio-equivalence assessments
- GLP/GcLP compliant
- CDISC standards
- Biosimilars
Study design
- Pre-clinical and clinical studies
- In-house method development and validation for Ab titres, ADA and NADA
- Calculation of PK parameters (WinonLin)
- GLP/GcLP compliant
- CDISC standards
Biomarkers
- Understanding biomarkers for better drug discovery and development
- Scientific expertise for biomarker selection (clinical fields, biological pathways, biofluids)
- Proteins: cytokines, hormones, peptides etc.
- Small molecule biomarkers – hormones, peptide fragments etc
- Metabolites and intermediaries
- Validated biomarker panels
- Biomarkers analytical method development (ELISA, MesoScale, LCMSMS)
- Biomarkers validation in GLP and GCP environments
Immunogenicity
- Immunoassays and assessment of potential immunogenicity
- Anti-vaccine antibody titres
- In-house development and validation (FDA and EMA Guidelines)
- ADA Screening assay and ADA Confirmatory assay
- ADA Neutralising assay, cell culture facilities
- Reagent preparation
- GLP/GcLP compliant
ADC (Antibody Drug Conjugates)
- ADC (Antibody-Drug Conjugates)
- tADC and tMAB analysis by ELISA/ECL
- Payload analysis by LCMSMS
- ADA assessment
- All analyses in the same laboratory on the same sample
- From early stage to clinical trials
- In-house preparation of conjugates for bio-analysis
- GLP/GcLP compliant
Topical product development
- In vitro / In vivo application of topical products
- Franz diffusion cells, Bronaugh diffusion cells, PhoenixTM Dry Heat system
- In Vitro Release Test (IVRT)/ In Vitro Permeation Test (IVPT)
- Skin distribution with radiolabelled (14C/3H) or cold compound
- Clinical dermal absorption, tape stripping, PK and Bioequivalence
- Bioanalytical method, development and validation for skin matrices
- Cosmetics, Pharmaceuticals, Safety Testing, formulations comparisons
- GLP compliant, OECD 428, SCCS guidelines
Anatonomical Pathology
The deployment of pathology testing has become increasingly important in safety, vaccine and oncology trials.
Eurofins offers anatomic, clinical and molecular pathology services to assess traditional clinical-pathological factors as well as the molecular biological features of a given tumor to support safety, vaccine and oncology trials.
- Surgical pathology
- Tumor confirmation and classification
- Pathology reads for efficacy
- Slide preparation and preservation
- Histology
- Cytology
- Molecular pathology
- FISH
Genomics
As the largest microarray service provider in Europe for Illumina and ThermoFisher arrays we are able to offer you a broad portfolio of services.
From standardized products like oligonucleotides, Sanger sequencing and gene synthesis to highly customized project based services, we fast-track your path to the next blockbuster drug using next generation sequencing (NGS), microarrays and qPCR/dPCR with rapid turnaround times as well as industry leading quality.
- Broad variety of successful genotyping and qPCR studies.
- dPCR analyses to detect and quantify gene therapy viral vectors.
- Our NGS laboratory in Germany, founded in 2006: the first European service provider in Europe
- high-quality oligonucleotides tailored for your needs in BioPharma applications using exclusive synthesis technology, including synthesis of Genes and GeneStrands accredited according to ISO 13485.
