In vitro & in vivo Toxicology services
Comprehensive Toxicological Assessment to Support Nonclinical Safety Evaluation
Nonclinical toxicology is fundamental to derisk discovery and later-stage drug development programs. At GBA Group, we deliver integrated in vitro and in vivo toxicology services that generate high-quality safety data, helping you make informed decisions and support regulatory strategies. Our in-house expertise and quality-controlled workflows ensure robust, reliable results tailored to your compound’s development needs.
Why Toxicology Matters in Drug Development?
Toxicology studies evaluate potential adverse effects of active ingredients before being administered to subjects and patients in clinical trials. These data help:
• Identify any hazard and safety issues early in the Research and Development process
• Guide dose selection, inform the therapeutic margins and support translational effort,
• Provide nonclinical safety pivotal studies required by regulators and health agencies
• Identify risks related to exposure and specific organ toxicity, reproductive effects, local tolerance, and mode of action, among others
Integrated toxicology programs support successful drug development by enabling early identification of potential safety risks and accelerating your progression from discovery through study completion and regulatory submission.
In Vitro Toxicology Services
We perform mechanistic, predictive and regulatory in vitro toxicology assays. They can identify and characterize potential safety liabilities of new drug candidates, help to refine subsequent in vivo study design and, to support translational activities. Assays are conducted under controlled conditions using relevant cell systems and modern analytical technologies.
Cytotoxicity
- Test systems
- Established cell lines and primary cells, 2D–monolayer, suspension and 3D-organoid cultures
- Analysis
- Fluorescence, luminescence, absorbance
- Indicator
- Resazurin, XTT, MTT, ATP, LDH
- Readout
- Viability, Cell Membrane Damage, energy content
Mitochondrial Toxicity
- Test Systems
- HepG2, HepG2-Oxphos
- Analysis
- Fluorescence, luminescence
- Indicator
- Resazurin, XTT, ATP
- Readout
- Viability
- Format
- 96-Well Plate/Plate Reader
- Multiplexing of analytical endpoints available
Metabolite Toxicity
- Test systems
- HepG2 w/ and w/o metabolic activation - by S9-Fraction
- Analysis
- Luminescence
- Indicator
- ATP
- Format
- 96-Well Plate/Plate Reader
- Metabolite identification via LC-MS
- Reactive metabolite trapping in liver microsomes
Immunotoxicity
- Test Systems
- PMBC, monocytes, blood
- Analysis
- Luminex technology
- Readout
- Lymphocyte subsets, cytokine levels
- Format
- 96-Well Plate/Plate Reader, Luminex
- Can be combined with other systems e.g. viability assays
- Recommended assays according to ICH S8
Hepatotoxicity
- Test systems
- HepG2, primary hepatocytes
- Analysis
- Fluorescence, luminescence, Luminex technology
- Indicator
- Resazurin, ATP
- Readout
- Viability, energy content, biomarker levels
- Format
- 96-Well Plate/Plate Reader, Luminex
Allergic Response / Histamine Release
- Test systems
- Peritoneal mastocytes
- Analysis
- Absorption
- Indicator
- O-phtaldialdehyde
- Readout
- Histamine release
- Format
- 96-Well Plate/Plate Reader
In vivo Toxicology
Our in vivo toxicology portfolio supports safety evaluation using well-designed, ethically conducted animal studies. Studies use OECD endpoints and can be customized.
Species & Model Support
- Rodent species for acute and short term studies
Addittional nonrodent species are available upon request through a partnership.
Species selection is tailored to scientific, ethical and regulatory requirements.
Routes of Administration
- Oral
- Intraperitoneal
- Intravenous
- Subcutanous
- Dermal
- Rectal
- Others
- (please contact us)
Acute Toxicity
- Systemic toxicity
- Phototoxicity
- Local tolerance
- Skin sensitization and irritation
- Others
- (please contact us)
Subchronic & Chronic Toxicity
- Rodents and non rodents
- Dose Range Finding (DRF) studies
- Maximun Tolerated Dose (MTD) studies
- Toxicokinetics
- Repeated dose pivotal studies between MTD and Toxicokinetics
Reproductive and Developmental toxicity
- Fertility and reproduction:
- Segment I: Fertility and Early development
- Segment II: Teratogenicity/Embryo-Fetal Development
- Segment III: Perinatal and postnatal development
- Juvenile study
Pathology
- Histology
- Immuno-histopathology
- Others
- (please contact us)
Carcinogenicity study (partnership)
- Rat, mouse
- Waiver
Safety Pharmacology (partnership)
- hERG and telemetry studies (rodent and nonrodent)
- Plethysmography
- Central nervous system models
- Ad hoc studies (in vitro and in vivo)
Further toxicological assays are available on request: We cover diverse therapeutic modalities, including small molecules, large molecules such as antibodies and ADCs, peptides, oligonucleotides, and PROTACs.
Quality Assurance & Regulatory Relevance
GBA Group conducts toxicology studies under quality-controlled processes and systems (GLP, ISO...) with rigorous data integrity. While nonGLP toxicology can inform early discovery and decision points, we operate in GIVIMP environment for research projects. We also conduct GLP bioanalysis of samples from all animal species to aid regulatory submissions, where applicable.
Our approach ensures that your toxicology data are:
- Scientifically robust
- Traceable and auditable
- Suitable for integrated safety assessments and/or regulatory submissions
Consultative Project Support
We work collaboratively with your team to:
- Tailor toxicology study design
- Integrate toxicology with DMPK and bioanalysis (exposure-effect)
- Interpret results in the context of overall drug research and development strategy
This consultative framework helps you optimize study value and meet project milestones with confidence.
Do you have questions?
I support pharmaceutical and biotechnology companies in selecting appropriate studies. Together, we will design an efficient testing strategy that delivers robust safety data and supports your development goals.
Dr. Daniel Da Costa
BD Director Preclinical Services Europe
+49 173 889 42 77
BD@pharmacelsus.de
✔ Personal consultation
✔ Fast response times
✔ Tailored solutions for your project
The experienced and highly committed GBA Group team offers a variety of different services the following in Areas:
Frequently Asked Questions — Toxicology Services
What toxicology studies do you offer?
We provide integrated in vitro and in vivo toxicology services, including cytotoxicity, immunotoxicity, hepatotoxicity, acute and (sub)chronic toxicity, reproductive toxicity, and carcinogenicity studies. Studies can be predictive or regulatory. They can also be mechanistic. Most of the studies are done internally or through partnerships. We ensure the coordination to speed up the drug development process.
Can you support GLP toxicology studies for regulatory submissions?
While many in vivo toxicology programs start with non-GLP exploratory assessments, we can support GLP-compliant in vivo studies, and bioanalytical analysis, in different species.
Which species are available for in vivo toxicology?
Primarily rodent species are supported for in vivo toxicology assessments. Additional nonrodent species may be available upon scientific justification and request. Only rodent studies are performed in the GBA facilities according to the 3Rs and the highest animal welfare standards.
How are toxicology studies integrated with other preclinical services?
Toxicology data are often integrated with DMPK, bioanalysis to inform safety margins, dose selection, and regulatory strategy, enhancing accurate selection of drug candidates and decision confidence throughout development.