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
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Hyderabad R and D Center
Bangalore R and D Center
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Resources
JUNE 28, 2022
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