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.
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)
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Combination of tests to assess genetic damage
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JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
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 contr...
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Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
Read MoreAlternate 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.
2021
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
2021
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
2021
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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