Genotoxicity is an adverse effect of a chemical on genetic material via variety of mechanisms, including mutation. In vitro 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.
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 Pharmaceutical Services?
Combination of tests to assess genetic damage
State-of-the-art facilities
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Resources
JULY 02, 2021
Oligonucleotide as a novel class of therapeutic modality
Oligonucleotides as a therapeutic class is a revolutionary approach to discover new and important therapeutic agents for treating human diseases. RNA-based intervention at times works in cases where other modalities do not work. For example, it may help in treating inborn errors in metabolism, genetic disorders and rareOligonucleotide therapeutics is the use of c...
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HPAPI Molecule from Development to Market
The global Highly Potent Active Pharmaceutical Ingredients (HPAPI) market is expected to reach USD 26.84 Billion by 2023 from USD 17.72 Billion in 2018, at a CAGR 8.7%....
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Gastro Retentive Dosage Form
Introduction: An orally-available anti-diabetic candidate that simultaneously targets all three key organs of diabetes: Pancreas, Liver and Muscles. This drug targets the two main defects seen in patients with type 2 diabetes: The pancreas by increasing insulin secretion, in a glucose-dependent manner; and the muscles and liver by decreasing the excess production...
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A metal catalyst-free and one-pot synthesis of (3,4- dihydro-2H-benzo[b][1,4]oxazin-2-yl)methanol derivatives in water
2015
A robust and metal catalyst-free method has been developed for the general and green synthesis of racemic (3,4-dihydro-2H-benzo[b][1,4] oxazin-2-yl)methanol derivatives. This simple, mild and practical method involves the reaction of 2-aminophenols with ()-epichlorohydrin in the presence of NaOH in water at room temperature. The reaction features high regioselec...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
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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