Early Stage

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

Early Stage

It is in the early stages of development that reliable information is required with a quick response time and at a competitive price.

Eurofins ADME Bioanalyses offers a range of services in-house to aid in the decision making process from first “in-life” studies to compare products and formulations to in-vivo and in-vitro metabolism studies.

We have the capacity to manage studies on large, molecules, small molecules and ADC with all conventional and novel delivery systems. 

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

Screening studies

• Non-GLP, all phases in-house, adaptable study design for lead selection
• Exploratory PK blood-brain barrier, tissue distribution, CSF
• Calculation of Cmax, Tmax, AUC, t½ , Cl, Vd, Bioavailability (F%), tissue exposure etc.
• Different rodent species, single or cassette dosing, all administration routes
• Microsampling:PK profile on the same animal
• Only a small quantity of compound is required​
• Standardised LC-MS/MS analytical development
• Rapid response: <2 weeks from agreement to study start
• Rapid turn-around: <2 weeks from reception of product to table of results
• Aggressive pricing policy to keep down development costs

CONCLUSION

Out of 1500 molecules studied:

• 99% passed the analytical test
• 52% were selected for the development phase (F> 20%)

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

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