While carbohydrates have the potential to develop various therapeutic drugs, there is an inherent structural complexity in developing these molecules. At Aurigene, we have a rich track record of having worked on all classes of carbohydrates such as Monosaccharides, Polysaccharides, Iminosugars, Carbocyclic sugars, Nucleosides, Locked nucleic acids (LNA), Glycopeptides, and Thioglycosides. We have capabilities across complex multi-step carbohydrates involving linear and convergent synthesis, Selective protection and deprotection, control of selectivity in moisture-sensitive glycosylation, handling of triflates, azide transfer, and oxidations. We also have hands-on experience in the use of glycosyl donors like SMethyl and STolyl and have capabilities in downstream purification and isolation involving water-soluble intermediates.
Lab Infrastructure
We have lab-scale operations of up to 100 grams per batch. Our purification infrastructure at the lab scale includes
- 1 Akta explorer ion exchange chromatography
- 1 Aktaprime plus ion exchange chromatography
- Gel permeation chromatography columns
Isolation techniques
We have distillation, precipitation, and lyophilization techniques for isolation. For lyophilization, we have Virtis Programmable Tray 3 L Capacity & Virtis Benchtop 4 L Capacity.
Manufacturing Infrastructure
Carbohydrates are manufactured in Hyderabad (CTO-2) and Visakhapatnam (CTO-6 and CTO-SEZ)
- Telescoping operations at a commercial scale
- Operation efficiency to remove chromatographic separation and use of simple techniques to limit impurities such as solubility and solvent-based extractions
- C-18 purification (up to 2 Kg of the crude compound)
- Gel Permeation Chromatography (GPC) purification
- Size exclusion chromatography
- Strong Anion Exchange (SAX) purification
- Water For Injection (WFI)
Analytical Capability
We have advanced analytical tools for the characterization of carbohydrates
Less or no chromophore substrates
- Evaporative Light Scattering Detection
- Refractive Index (RI)
- CAD detector
- Low wavelength UV detection
Highly polar substrates
- Range of specialized carbohydrate columns
- Ion exchange chromatography for polar moieties
Analysis of counter ions e.g., Na+, K+, SO42- SO32-
- Ion chromatography by conductivity detection
Characterization of API and its impurities by
- LC-QqQ-MS, LC-Tof instruments for characterization
- 600 MHz Nuclear Magnetic Resonance Spectrometry
Why Aurigene Pharmaceutical Services?
Experience of 20+ years
Comprehensive infrastructure at lab and plant for a full suite of services
State-of-the-art PAT tools and QbD approach to support optimization
Phase-appropriate development approach
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
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 lose. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.Drug discovery is a vast and ...
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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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Cell Line Development
We enable development of stable and high yielding recombinant Mammalian and Microbial lines. ...
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Advancing a target molecule from in vitro studies to clinical supply: An innovative scientific solution
Background: A biotech firm based in the USA contacted us to assist with the development and rapid supply of a non-GMP drug substance. This drug substance has been identified as a promising candidate for an anti-viral treatment. The synthesis of this drug substance involved various complexities, including process requirements, safety considerations, purification c...
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Base mediated spirocyclization of quinazoline: one-step synthesis of spiro-isoindolinone dihydroquinazolinones
2020
A novel approach for the spiro-isoindolinone dihydroquinazolinones has been demonstrated from 2- aminobenzamide and 2-cyanomethyl benzoate in the presence of KHMDS as a base to get moderate yields. The reaction has been screened in various bases followed by solvents and a gram scale reaction has also been executed under the given conditions. Based on the controll...
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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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