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We designed our early phase development of small molecule services to accelerate the journey of your clinical candidate from toxicology study to clinical stage. Our offering provides flexibility in terms of time and speed and focuses on speeding up the delivery of the program. Our services enable clients to have quick access to building blocks, intermediates and final drug substance from gram-scale to multi kilo-scale.

Our team of experienced process development scientists and analytical scientists have versatile experience in enabling the process from small-scale synthesis to large-scale manufacturing. The appropriate phase development serves as a bridge between discovery and development/manufacturing facilities to ensure rapid progress.

Our Services

  • Target hit identification
  • Route scouting
  • Familiarization
  • Enabling the process for scale-up with fit-for-purpose development

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Facilities

1. Process Research Lab

The laboratory has been designed with a fresh air system with ambiance and has a walk-in hood with a 5 liter jacketed reactor to quickly enable the scale-up with appropriate safety assessment on process and unit operations. There are multiple fume hoods with inbuilt fire suppression, gas detectors, sensors scrubbers, and appropriate engineering control for operational safety.

2. Analytical and Process Safety Lab

The lab has been collocated to enable the scientist to perform in-process testing and development studies in real-time. The state-of-the-art analytical lab is equipped with High-Performance Liquid Chromatograph (HPLC), Differential Scanning Calorimeter (DSC), microcalorimeter, and accessory equipment. The analytical testing capability also includes a Bruker 400-Megahertz Nuclear Magnetic Resonance (NMR), mass spectrometer, small scale preparatory HPLC, gas chromatography, analytical SFC, Karl-Fischer titrator, and combi flash torrent system.

3. Kilo lab

The lab consists of stainless steel jacketed cylindrical glass reactor (10 liters to 50 liters), a Huber thermic fluid circulation system (operating temperature of -20 °C to 150 °C) with a cumulative reactor capacity of 150 liters.

The reactors are designed with high vacuum distillation. The facility has other downstream equipment like Pressure Nutsche Filter (PNF), rotavapor of 20 liters capacity, vacuum tray dryer and temperature control storage. The facility can cater to perform the air and moisture sensitive reactions and metal promoted reactions. The facility also has a 50-liter autoclave to perform the high-pressure hydrogenation with design pressure 20 Bar to cater the small-scale hydrogenation and an autoclave (500 milliliter to 10 liter) with similar design pressure is also available for enabling gram to kilo scale.

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research, develoment and manufacturing services

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