Phase III

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

For more information on each of our services please click on the heading below

Phase III

Phase III studies require reliable, GLP compliant analyses with dependable turnaround times and seamless integration into dossier submissions.

Eurofins ADME Bioanalyses offers state-of-the-art bioanalytical services to support clinical trials run by Eurofins own Central Laboratory services or with a client’s own choice of clinical phase supplier.

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

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

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, 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