We characterize the potential genotoxicity of compounds using various test and assays:
In vivo micronucleus test Chromosomal aberration test Traditional Ames assay
The in vivo micronucleus assay (in vivo MNT) is a reliable and commonly-employed test to meet the regulatory requirements while submitting IND, to screen the compounds (such as chemicals, impurities, pesticides, insecticides, food and feed additives) for their clastogenic potential in bone marrow of rodents (rats/mice) and as a component of exposure-based risk assessment. This assay plays a vital role in adding weight of evidence in the hazardous measurement of any chemical and quantitative risk assessments.
The Chromosomal Aberration Test (CAT) is routinely employed as part of NPD and to meet regulatory expectation to screen the compounds (such as chemicals, impurities, pesticides, insecticides, food and feed additives) for their clastogenic potential to cells (human blood lymphocytes or mammalian cell lines in culture) by evaluating the development gene/chromosome damage in the form of structural aberrations at chromosome level.
Ames test is a rapid and reliable bacterial assay used for evaluating a chemical's potential genotoxicity by measuring its ability to induce reverse mutations at selected loci of modified Salmonella and E. coli bacterial strains. These strains have various mutations and are not capable of synthesizing an essential amino acid, either histidine (Salmonella) or tryptophan (E. coli), so they can only grow in the culture medium that is supplemented with that amino acid. Once the bacteria are exposed to a mutagen, mutation(s) occur that could restore/reverse the ability of the bacteria to synthesize the amino acid and to continue growth even after depletion of traces of provided amino acid in the agar. Relevant mutations involve substitution of individual base pairs or frameshift mutations caused by addition or deletion of a stretch of DNA. The Ames test can be carried out in the presence and absence of a metabolizing system to identify potential mutagenicity by the parent compound and/or its metabolites.
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Resources
MAY 19, 2023
“Bathtub Chemistry” - Necessity and Aspects of Process Research
Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they loss. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.  ...
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contract development and manufacturing organizations (CDMOs) for collaborations as they seek more adaptable capacity and c...
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How the re-designed synthesis of a complex carbohydrate can reduce cycle time
Project challenge: Complex carbohydrate chemistry involving a linear sequence of 10 chemical transformations, unstable intermediates and column chromatographic purications. Solution design: Process research and optimization was performed to develop a robust and scalable process which was implemented on commercial scale. Telescoping of reactions reduced the number...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2023
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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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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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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Simple and efficient synthesis of imidazoquinoxalines and spiroquinoxalinones via pictect-spengler reaction using Wang resin, Synthetic Communications
2005
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...
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