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Carbohydrate Development and Manufacturing Services

Carbohydrate Development and Manufacturing Services

Aurigene offers innovative solutions for custom synthesis, analysis and GMP manufacturing of complex multi-step carbohydrates.

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.

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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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