In vitro ADME services for NonClinical drug development
Supporting Lead selection, PK/PD Characterization & Safety Assessment Decisions
In Vitro ADME (Absorption, Distribution, Metabolism, Excretion) is a cornerstone of drug discovery and preclinical development. At GBA Group, our in vitro ADME team offers customized, regulatory compliant assays that generate high-quality data necessary for guiding the lead selection, dosing strategies, and regulatory-compliant programs.
Why In Vitro ADME Matters in Drug Development ?
Understanding how a compound behaves before it goes into in vivo testing is essential to reduce development risk and to identify the most promising lead candidate). In vitro ADME studies help you to:
• Assess compound druggability and developability
• Predict exposure, through bioavailability testing
• Identify potential metabolic liabilities and drug-drug interactions (DDI)
• Inform early dose and safety decisions for regulators and project teams
Our In Vitro ADME Capabilities
Physico-Chemical Parameters
- Chemical stability
- Aqueous solubility
Stability in Biological Matrices
Prediction of systemic exposure, Species selection for in vivo studies and Interpretation of metabolism data
Matrices include:
- Blood
- Plasma
- Intestinal fluids
- Further matrices on request
- All preclinical species available
Membrane Permeability & Transport
- PAMPA
- Bidirectional Caco-2 permeability
- Artificial blood-brain barrier (BBB) models
- Transporter interaction profiling (e.g., P-gp, SLC families)
Drug Transporter Interaction Studies*
- ABC-ATP binding assays
- SLC transporters:
inhibition/uptake - PgP specific interaction assays
- Transporters from different organs (Liver, Kidney, Intestine and Brain) from different species are available.
*in cooperation
Protein & Tissue Binding
- Plasma Protein Binding (PPB) (cross-filtration or rapid equilibrium dialysis)
- Microsomal and tissue binding
- Brain tissue binding in rat and mice matrices (ultrafiltration and rapid equilibrium dialysis)
Metabolic Stability & Metabolite Characterization
- Microsomes (liver and intestine)
- S9 fractions (Liver and intestine)
- Hepatocyte systems
- Metabolite identification and pathway elucidation
Reactive metabolite Trapping
- Liver microsomes
- By glutathion or semicarbazide
- Hepatocytes
- All preclinical species available
Metabolite Identification
- Liver or intestinal microsomes
- Liver or intestinal S9 fraction
- Hepatocytes
- Metabolic pathway
CYP Inhibition
- Recombinant human CYPs
- IC₅₀ determination
- Human liver microsomes*
- Mode of inhibition, inhibition kinetics
*according to EMA/FDA Guidelines
CYP Induction
- Hepa RG®
- Human hepatocytes
- Functional activity
- mRNA
CYP Phenotyping
- Recombinant human CYPs
- Loss of parent compound
- Clint
- Half-Life
- Formation of major Phase 1 metabolites and metabolic Pathway Elucidation
Regulatory Alignment & Data Quality
All in vitro ADME services at GBA Group are performed using validated protocols and experienced scientists. Data is generated to support:
• Lead prioritization
• PK/PD modeling
• Safety assessment
• Regulatory submissions
Tailored, Consultative Service
Our approach is highly consultative. We work with your project team and experts to:
• Select the most appropriate assays
• Adapt protocols to your compound class and therapeutic area
• Provide meaningful, actionable results
• Integrate your ADME data with in vivo DMPK, toxicology and bioanalytical strategies
This close collaboration ensures insight that drives better decisions with fewer surprises later in development. We cover diverse therapeutic modalities, including small molecules, large molecules such as antibodies and ADCs, peptides, oligonucleotides, and PROTACs.
Our expert
Dr. Julia Przibilla
Study Director In Vitro ADME
Julia, why do you like ADME?
What I like most about ADME is the opportunity to apply strong science to practical questions and contribute meaningfully to the success of drug discovery projects.
What do you do outside work?
Outside the lab, I also enjoy spending time with my family, especially outdoors – camping, skiing, and staying active together.
Interested in Integrated Preclinical Support?
We also offer:
• In vivo DMPK services
• In vitro & in vivo toxicology studies
• Safety pharmacology studies
• G(C)LP & non-GLP Bioanalytics analysis
• Biomarker Services
Explore our full nonclinical services portfolio to build a cohesive development strategy.
Our Flyers
Frequently Asked Questions – In Vitro ADME Studies
What are in vitro ADME studies used for?
In vitro ADME studies are used in early drug discovery and preclinical development to evaluate how a compound is absorbed, distributed, metabolized, and excreted. These assays help identify developability risks, guide lead selection before performing in vivo studies.
Are in vitro ADME studies required for regulatory submissions?
While in vitro ADME studies are not submitted as stand-alone regulatory studies, they are an essential component of regulatory submissions. ADME data supports dose selection, inform drug-drug interaction risk assessment and the nonclinical safety package.
Which compounds are suitable for in vitro ADME testing?
In vitro ADME assays can be applied to a wide range of compound classes, including small molecules and selected modalities. Assay selection and protocol design are typically adapted based on the physicochemical properties and development stage of the lead compounds.
Do you offer customized in vitro ADME study designs?
Yes. In vitro ADME services are offered on a flexible and consultative basis. Assays, species, and experimental conditions can be tailored to align with specific project goals, compound characteristics, and downstream regulatory strategies.
How does in vitro ADME data support in vivo studies?
In vitro ADME results help inform: • Species selection for in vivo studies • Formulation strategies, route and dose selection • Interpretation of pharmacokinetic and safety data • Identification of metabolism-related risks This integration reduces late-stage surprises and improves study efficiency.
Are your in vitro ADME studies performed under GLP?
In vitro ADME studies are generally conducted using validated, fit-for-purpose methods. Studies are typically non-GLP but performed in GLP-certified environment, which is aligned to data integrity expectations and ensuring data reliability and traceability.