Genetic toxicology
Genotoxicological studies predict the genotoxicity of drugs and chemicals, including mutagenicity, destructiveness, and DNA damage. We can offer our customers the full range of tests in the ICH S2(R1) standard portfolio and comply with international GLP management specifications. The protocol was designed to meet the requirements of the US FDA, US EPA, ICH, OECD and CFDA guidelines. A rich historical database accumulated over the years, a stable technical team and professional senior researchers ensure that we are able to provide high-quality services to our customers in a timely and efficient manner. We are committed to developing cutting-edge genotoxicity methodology research, applying automated systems such as flow cytometry to genotoxicology, and participating in the joint validation of new technologies and methods of genotoxicity both domestically and internationally. In addition to the ICH standard test portfolio, we can also provide our customers with genotoxic mechanisms and additional test methods, as well as genotoxic evaluation of impurities that meet the requirements of ICH M7.
Category: Non-clinical safety evaluation
Medicines for human purposes
Genotoxicological studies predict the genotoxicity of drugs and chemicals, including mutagenicity, destructiveness, and DNA damage. We can offer our customers the full range of tests in the ICH S2(R1) standard portfolio and comply with international GLP management specifications. The protocol was designed to meet the requirements of the US FDA, US EPA, ICH, OECD and CFDA guidelines. A rich historical database accumulated over the years, a stable technical team and professional senior researchers ensure that we are able to provide high-quality services to our customers in a timely and efficient manner. We are committed to developing cutting-edge genotoxicity methodology research, applying automated systems such as flow cytometry to genotoxicology, and participating in the joint validation of new technologies and methods of genotoxicity both domestically and internationally. In addition to the ICH standard test portfolio, we can also provide our customers with genotoxic mechanisms and additional test methods, as well as genotoxic evaluation of impurities that meet the requirements of ICH M7.
Test system
Cells: CHL, CHO, TK6, L5178Y, 3T3, etc. (purchased from ATCC)
S9 (Purchased from MOLTOX)
Strains (purchased from MOLTOX) :
Salmonella typhimurium: TA97a, TA98, TA100, TA102, TA1535, TA1537
E. Coli WP2 uvrA and E. Coli WP2 uvrA (pKM101)
Core assembly test
Ames Test (OECD 471)
In vitro and in vivo chromosome aberration tests (OECD 473/475)
Genetic mutation test (MLA, HGPRT or XGPRT) (OECD 490/476)
In vitro and in vivo micronucleus test (Manual & FCM) (OECD 487/474)
Comet Assay IV software for multiple organs in vivo (OECD 489)
Additional trial/mechanism studies
In vitro and in vivo Pig-a gene mutation tests
Multiendpoint genotoxicity tests (gamma-H2AX, p53, H3, Cleaved-PARP)
In vivo liver micronucleus test
