Human Medicinal Products
Human Medicinal Products - Genotoxicity
GLP In vitro Genotoxicity Testing for Human Medicinal Products
Reliable GLP Studies for Regulatory Compliance and Pharmaceutical Development
Looking for a trusted GLP laboratory for genotoxicity testing? LAUS supports pharmaceutical and biotechnology companies with regulatory-compliant studies for human medicinal products, from early preclinical development to impurity assessment according to current ICH and OECD guidelines.
Our experienced scientific team provides high-quality genotoxicity data generated under the principles of Good Laboratory Practice (GLP).
GLP Genotoxicity Testing Services
We offer GLP genotoxicity testing for active pharmaceutical ingredients (APIs), pharmaceutical impurities, degradation products, and intermediates.
Genotoxicity Testing of Pharmaceutical Impurities
According to ICH Q3A (R2), impurities exceeding the applicable identification thresholds require appropriate characterization. In addition, ICH M7 requires the assessment of DNA-reactive (mutagenic) impurities, which may present a carcinogenic risk even at very low concentrations.
Our laboratory offers:
- OECD 471: Ames Test – Bacterial Reverse Mutation Test
- mini-Ames (Ames MPF Test) – ideal for limited sample quantities or difficult-to-synthesize impurities
GLP Genotoxicity Testing for Human Medicinal Products
Genotoxicity assessment is an essential component of the pre-clinical safety evaluation of pharmaceuticals intended for human use.
In accordance with ICH S2 (R1), a stepwise testing strategy is recommended to evaluate the mutagenic and genotoxic potential of new drug substances before clinical development and regulatory submission.
Mutagenicity Assessment
Test for gene mutation in bacteria:
- OECD 471: Ames Test
- mini-Ames (Ames MPF Test)
In Vitro Genotoxicity Testing
Our GLP laboratory performs the key in vitro assays recommended by international regulatory authorities:
- OECD 487: In vitro Micronucleus Test
- OECD 490: In vitro Mouse Lymphoma Tk Gene Mutation Assay
- OECD 476: HPRT Gene Mutation Assay
Depending on the study outcome and regulatory strategy, positive in vitro findings may require additional in vivo follow-up testing.
Every pharmaceutical development program is unique. We are happy to advise you on the most appropriate testing strategy.
Contact our GLP experts today to discuss your project or request a customized quotation.
