Genetic Toxicity
Services
Ames Test
In vitro Chromosome Aberration Test
In vivo and In vitro Micronucleus Tests
Animal Species
Rodents
Rats (SD, Wistar)
Mice (ICR, KM, C57BL/6, Transgenic Mice)
Non-rodents
Rabbits (New Zealand White, Japanese White)
Non-human Primates (Cynomolgus Monkeys)
Strains and Cell Line
Strains
TA97a, TA98, TA100, TA102, TA1535
Cell Line
CHL (Chinese Hamster Lung Cells)
Service Advantages
Extensive experience in standard reproductive and developmental toxicity evaluation studies (Seg. I, Seg. II, and Seg. III), covering a wide range of drug types including small molecules, biologics, small nucleic acids, gene therapy products, etc.
The experimental design for the combined reproductive and developmental toxicity evaluation for vaccines has been reviewed and approved multiple times by domestic authorities and the FDA.
Established the first evaluation model for embryo-fetal developmental toxicity studies in Cynomolgus monkeys in China and completed multiple GLP ePPND studies in Cynomolgus monkeys for new drug registration applications.
Extensive experience in the application of surrogate molecules and transgenic animals in reproductive and developmental toxicity evaluation of biologics.
Extensive experience in conducting Segment II reproductive toxicity studies in rabbits, with proficiency in artificial insemination techniques for rabbits.
Mature in vitro whole embryo culture methods for screening early drug development and reproductive toxicity studies.
Standard GLP laboratory, professional technical team, comprehensive technical platform, and extensive evaluation experience.
