With strong expertise on molecular biology, pharmacokinetics and pharmacodynamics studies, we offer comprehensive preclinical services on multiple key-steps of your preclinical development program in oncology.
Our Preclinical Services include
- We have a panel of more than 60 well-characterized human tumor cell lines, most of which were developed and characterized for their resistance to more than 20 chemotherapy agents or targeted therapies and for common relevant genetic mutations.
- Validation of drug proof-of-concept, compound efficacy and molecular mechanism of action, through a broad range of modern and advanced laboratory tools for molecular and cellular biology assays:
- Cell proliferation assays (MTT, LDH, clonogenic).
- Evaluation of primary or acquired drug resistance to determine molecular mechanisms of action and predictive factors of drug sensitivity.
- Drug combinations studies (Chou-Talalay).
- Cell migration and invasion assays (Boyden Chamber, Gap Closure).
- Evaluation of protein expression (Western blot, ELISA) and mRNA levels (PCR, qRT-PCR).
- Intracellular signaling pathways exploration and proof of concept of therapeutic targets (cell transfections, RNA interference technology).
- Immunohistochemistry and immunofluorescence and FISH.
- Gene expression profile studies (HumanHT-12 v4 Expression BeadChip).
- Evaluation of drug efficacy and drug schedule optimization.
- Evaluation and validation of predictive or pharmacodynamic biomarkers.
- Broad experience in animal models:
- Xenografts models including mice “clinical trials” using first-line and second-line treatments after in vivo resistance acquisition to a variety of standard therapies.
- Murine orthotopic models.
- Syngenic models, particularly relevant for studies of immunotherapies.
- Experimental models of tumor metastasis.
- Assessment of small molecules and monoclonal antibodies distribution in small animals using Copper-64 (Cu-64) and Galium-68 (Ga-68) radiolabeling techniques to validate the mechanism of action.
- Bioanalytical method validation for new leads and metabolites according to GLP rules.
- Drug pharmacokinetic profiling of novel leads and their metabolites.
E2DG pharmacological team is compliant with FDA/EMA GLP standards.
Our preclinical team follows rigorous standard operating procedures to ensure the consistency and regulatory compliance of our results.
FDA Science & Research
European Medicines Agency