We are committed to the highest standards of Environment, Health and Safety. We follow a very robust and systematic approach to ensure risk assessment and safety studies. We also evaluate alternative options to adopt safer processes throughout our research from development to manufacturing and safe handling of powders.
We offer process and powder safety assessment studies prior to manufacturing, irrespective of the phase of the molecule.
Safety Assessment using Literature and Database
- Review of the synthetic scheme for the potential hazards’ functionalities and gaseous by-products
- Assessing the hazardous nature of reagents or solvents used for the conversions by referring to the available data such as material safety data sheet (MSDS) and Brethrick's handbook of reactive chemical hazards. Review of the reaction parameters such as temperature and pressure
Safety Assessment : Screening Tests and Instruments
- Basic safety screening tests which include:
- Differential scanning calorimetry (DSC) for reaction masses, organic layers, mixtures, intermediates, etc.
- Thermal Screening Unit (TSU) studies
- Reaction Calorimetry (RC1mx)
- Accelerating Rate Calorimetry (ARC)
- Powder safety studies which include:
- Minimum ignition energy (MIE)
- Bulk powder resistivity test
- BAM Fall Hammer test
- Burning behavior
- Dust explosion
Why Aurigene Pharmaceutical Services?
Safety evaluation labs with infrastructure to support calorimetry, thermal screening and powder safety
Stringent SOPs for risk evaluation and stage wise risk assessment and safety reports
Assessed 500+ compounds
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Hyderabad R and D Center
Bangalore R and D Center
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Resources
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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