Bioneeds
OECD GLP-certified preclinical CRO near Bengaluru providing regulatory toxicology for pharmaceuticals, biologics, devices and chemicals.
About Genetic Toxicology
Genetic toxicology tests whether a compound can damage DNA or chromosomes. For small-molecule drugs the standard battery is set out in ICH S2(R1): a bacterial reverse mutation (Ames) test, plus either an in vitro mammalian cell assay and an in vivo test (option 1), or an in vivo assessment in two tissues (option 2). Ames testing is also used under ICH M7 to qualify potentially mutagenic impurities.
In vitro mammalian assays include the micronucleus test (OECD 487), the chromosomal aberration test (OECD 473) and the mouse lymphoma assay (OECD 490). In vivo, the rodent micronucleus test (OECD 474) is often built into a repeat-dose toxicology study to save animals and time, and the comet assay (OECD 489), frequently in liver, is a common second tissue. Biologics generally do not need the standard battery under ICH S6(R1), though conjugates with novel linkers or payloads may.
Under ICH M3(R2), an Ames test is generally expected before first-in-human dosing, a chromosomal damage assay before multiple-dose trials, and the full battery before phase 2. In vitro genotoxicity tests are relatively quick and inexpensive, so many sponsors also run non-GLP screening versions during lead optimization.
Genetic Toxicology CROs
Showing 10 CROs. Order rotates daily so no lab is permanently listed first.
Jai Research Foundation (JRF)
Indian GLP CRO providing regulatory toxicology and safety studies for pharmaceuticals, agrochemicals, chemicals and biologics.
International Institute of Biotechnology and Toxicology (IIBAT)
Indian GLP test facility offering regulatory toxicology studies for chemicals, agrochemicals and pharmaceuticals.
Biotoxtech
Korean non-clinical CRO offering IND and NDA-enabling GLP toxicology, including general, reproductive and genetic toxicity, carcinogenicity and safety pharmacology, with NHP capacity through its group companies.
Research Toxicology Centre (RTC)
Italian GLP CRO near Rome providing regulatory toxicology and safety studies for pharmaceuticals, chemicals and agrochemicals.
Toxi-Coop
Hungarian non-clinical CRO founded in 1982 offering GLP general, genetic and reproductive toxicology for pharmaceutical, chemical and agrochemical sponsors.
BSL Bioservice
Munich-area contract laboratory providing GLP toxicology, genetic toxicology, biocompatibility and microbiology testing for pharmaceutical, chemical and medical device sponsors.
Eurofins Advinus
Bengaluru-based preclinical CRO, part of Eurofins, offering GLP safety assessment, DMPK and discovery services for pharmaceutical and agrochemical sponsors.
Scantox
GLP-accredited preclinical CRO headquartered in Denmark with sites in Sweden, Austria and the UK. Known for Gottingen minipig work and regulatory toxicology, with discovery pharmacology including CNS and…
BoZo Research Center
Long-established Japanese preclinical CRO providing toxicology, carcinogenicity, genetic toxicity and pharmacology studies.
Questions to ask when choosing a Genetic Toxicology CRO
- Are your Ames, in vitro micronucleus and in vivo micronucleus assays run under GLP, and when was your last inspection?
- Can the in vivo micronucleus or comet endpoint be integrated into our rodent repeat-dose study?
- What historical negative and positive control data do you hold for each assay?
- How do you handle compounds that are cytotoxic or poorly soluble at the top concentration?
- Do you offer non-GLP screening versions of these assays for lead optimization?