Genetic Toxicology & Impurity Qualification
Ames Test
Vanta has conducted the Ames test across a wide range of substance classes — including drug candidates, impurities, metabolites, and formulated agrochemical products — with extensive experience addressing solubility and cytotoxicity challenges. Our validated in-house protocols, historical solvent control databases, and experienced GLP study directors ensure reliable, interpretable results.
In-vitro Micronucleus
Applies fully validated protocols with documented historical control ranges, supporting the scientific defensibility of positive, negative, and equivocal findings. Our team has experience navigating cytotoxicity interference and precipitate formation issues that frequently challenge in-vitro genotoxicity assessments.
In-vivo Micronucleus
Vanta Bioscience integrates in-vivo micronucleus studies with ongoing toxicology studies where scientifically appropriate, using dose levels informed by existing TK data to optimize relevance and animal use efficiency. Our experienced in-vivo genotoxicology team ensures appropriate scoring, statistical analysis, and regulatory reporting.
ICH M7 Impurity Qualification
Provides end-to-end ICH M7 qualification support, including bacterial reverse mutation assays conducted under GLP for impurities and degradation products. Our team has supported ICH M7 sections of multiple NDA and MAA submissions, with structured documentation designed to integrate directly into regulatory dossiers with minimal sponsor effort.
NDSRIs (Nitrosamine Risk Assessment)
Vanta supports NDSRI risk assessment through in-silico potency categorization, literature-based hazard evaluation, and, where required, experimental genotoxicity testing. Our scientific team stays current with evolving agency guidance, enabling sponsors to build defensible NDSRI control strategies. We have supported NDSRI assessments across a range of drug classes and manufacturing platforms.
Genotoxic & Mutagenic Impurity Evaluation
Conducts tailored impurity qualification programs combining structural hazard assessment, TTC evaluation, and confirmatory in-vitro genotoxicity testing. Our team provides detailed written justifications for qualification decisions formatted for direct inclusion into regulatory submissions, reducing the risk of deficiency queries.
Metabolite & Degradation Product Safety
Supports the full metabolite and degradant qualification workflow, from structural identification and in-silico toxicity prediction through to targeted in-vitro genotoxicity and cytotoxicity testing. Our scientists have experience working with chemically reactive, poorly stable, and low-abundance species that present practical challenges in assay preparation and handling.
Threshold of Toxicological Concern (TTC) Assessments
Conducts TTC evaluations using validated in-silico structural alert tools, including Derek Nexus and Sarah Nexus. Our experienced regulatory scientists provide complete TTC assessment reports formatted for direct submission to health authorities, covering structural class assignment, Cramer classification, exclusion criteria evaluation, and justified limit derivations.