Pre-Clinical

Eurofins ADME BIOANALYSES services span the complete drug development cycle for new chemical entities (NCE), biologics and generics.

Pre-Clinical

Pre-clinical development demands both GLP and non-GLP studies in-vivo and in-vitro.

Eurofins ADME Bioanalyses offers a range of bioanalytical services in-house with in-life phases in partnership with other Eurofins companies for toxicology, pharmacokinetic and pharmacological studies.

Method development and method validation for large and small molecules and ADC with over 30 years of experience. Both FDA and EMA guidelines.

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

Pre-clinical PK/TK

• Pharmacokinetics, Toxicokinetics and systemic exposure
• All pre-clinical species
• In-house bioanalytical method development & validation
• Extrapolation to predict First-In-Man dosage
• GLP compliant
• SEND format

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

ADME studies

• ¹⁴C/³H radiolabelled or cold compounds
• Blood/plasma kinetics, PK analysis
• Excretion evaluation, Mass balance
• Tissue distribution
• Biliary excretion
• Metabolite profiling
• GLP compliant

In-vitro metabolism

• Hepatocyte metabolism
• Microsome metabolism
• Protein binding
• Metabolite profiling

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, Phoenix^TM 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

Veterinary product development

• Exploratory Pharmacokinetics
• Small molecules/Large molecules/Biologicals
• Bioequivalence, all species (production and companion)
• Residue depletion studies in all production species
• In-house method development – all matrices
• Topical product development
• Validation to VICH Guideline 49
• Immunogenicity
• GLP compliant