Genotoxicity is an adverse effect of a chemical on genetic material via variety of mechanisms, including mutation. Genotoxicity testing is very crucial to determine potential carcinogenic or mutagenic compounds that can cause genetic alterations in somatic or germ cells, and this information is used in regulatory decision-making. Mutagenicity (gene mutation and structural and numerical chromosomal alterations) is one of the six basic testing areas that have been adopted by the Organization for Economic Co-operation and Development (OECD, 2011) as the minimum requirement to screen high-production volume chemicals for toxicity.
We provide a combination of tests to assess three major endpoints of genetic damage
- Gene mutation (i.e. point mutations or deletions or insertions that affect single or blocks of genes)
- Clastogenicity (i.e. structural chromosome changes)
- Aneuploidy (i.e. the occurrence of one or more extra or missing chromosomes, leading to an unbalanced chromosome complement).
In vitro genotoxicity testing
- Bacterial reverse mutation test (OECD 471)
- In vitro chromosomal aberration test using human blood lymphocytes (OECD 473)
- In vitro micronucleus test using human blood lymphocytes (OECD 487)
- Mammalian cell gene mutation assay (OECD 490)
Why Aurigene In vitro Genotoxicity Testing Services?
Combination of tests to assess genetic damage
State-of-the-art facilities
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Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
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Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Resources
FEBRUARY 25, 2025
Transforming Drug Discovery with Aurigene.AI
In the early 2000s, developing Sovaldi, a hepatitis C treatment, took over a decade and nearly $2 billion. Similarly, Zolgensma, a gene therapy for spinal muscular atrophy, required 15 years due to its complexity. However, the advent of artificial intelligence (AI) has revolutionized drug discovery. For example, in 2022, Pfizer's PAXLOVID, an oral COVID...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role...
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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Familiarization, process optimization, and cGMP manufacturing and supply of 30.0 kg of a Bioactive Nucleotide (NAD Booster)
Background: A US-based biopharmaceutical company approached Aurigene Pharmaceutical Services for the familiarization, process development, and cGMP manufacturing and supply of 30.0 kg Nucleotide product (NAD booster) for phase-appropriate studies. The synthesis of the desired product involves three linear stages, which starts with reaction of a pentose...
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Identification of Degradants of Thermal and Oxidation Stress Studies of Empagliflozin and Linagliptin Tablets by HPLC-PDA and LC-MS Instrumental Techniques
2022
Objective of the manuscript is to identify the degradants observed in the thermal and oxidation degradation sample of Empagliflozin and Linagliptin tablets by using LC-MS and HPLC-PDA instrumental techniques. Thermal and oxidation degradation samples were injected in HPLC-PDA and LC-MS instruments. Mass of the degradants were detected by LC-MS technique, ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
2005
The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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Polycyclic Aromatic Compounds: A Simple and Efficient [(n-Bu3Sn)2MO4]n Catalyzed Synthesis of Quinazolinones and Dihydroquinazolinones
2005
A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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