Bacterial Reverse Mutation Test (Ames Test)
•Adopts standard strains including TA97a, TA98, TA100, TA102 and TA1535.
•Sets multiple dose groups, positive and negative control groups, and conducts tests with and without metabolic activation synchronously.
•Records revertant colony counts and judges test results in strict accordance with GLP specifications.
In Vitro Chromosome Aberration Test
•Uses the standard CHL (Chinese Hamster Lung) cell line.
•Sets concentration gradient groups as well as positive and negative controls for short-term and long-term exposure tests.
•Observes types of chromosome aberrations under microscope, calculates aberration rates, and delivers GLP-compliant reports.
In Vitro and In Vivo Micronucleus Test
•The in vitro micronucleus test adopts CHL cell lines; the in vivo test uses SD rats, Wistar rats, ICR mice and other rodent species.
•Standardizes the setting of dose groups and control groups.
•Detects micronucleus rates in bone marrow and peripheral blood, and conducts testing and data analysis under full GLP compliance.
•Possesses extensive experience in standardized genetic toxicity evaluation, covering small molecules, biologics, oligonucleotides, gene therapy products and other test articles.
•Establishes dedicated combined genetic toxicity evaluation strategies for vaccines, with multiple projects successfully reviewed by domestic regulators and the FDA.
•Takes the lead in applying surrogate molecules and transgenic animal models for biologic genetic toxicity assessment in the industry.
•Adopts a mature whole embryo culture system for rapid early-stage genetic toxicity screening.
•Equipped with standardized GLP laboratories and professional technical teams with full-process quality control to ensure fully traceable and compliant data.
