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Early Phase Development and Pilot Facility Services Early Phase Development and Pilot Facility Services

Early Phase Development and Pilot Facility Services

Early phase development and pilot facility at Aurigene Pharmaceutical Services enables smooth and rapid transition of small molecules from discovery to pre-clinical requirements.

The services at Aurigene enable clients to have quick access to building blocks, intermediates, and final drug substances from gram-scale to multi-kilo-scale. The team comprises of analytical, process development scientists and engineers having expertise in small-scale synthesis to large-scale manufacturing. The accelerated delivery of pre-clinical candidates to the customer expectation is driven by phase appropriate development approach.    

We offer technical services in various segments FTE and FFS projects Target Synthesis Process R and DPeptidesOligonucleotidesLipidsTox and pre-clinical studies We have 3 kilo lab facilities for scale-up Hyderabad- 20 and 50 L Bangalore- 5, 10, 20, 50 L Hyderabad, Potent lab- 20 and 50 L Our Services Target hit identification Route scouting Phase appropriate development Standalone FFS target deliveries

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Lab and Pilot Facility

The process, analytical and pilot facility are co-located and are designed with appropriate modular fume hoods, gas detectors and with engineering control for operational safety.

Analytical and Process Safety Lab

The lab enables the scientists to perform in-process testing and development studies in real-time. The state-of-the-art analytical lab includes 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.

Pilot Facility

The lab consists of a jacketed cylindrical glass reactor (10 L to 50 L), a Huber thermic fluid circulation system (operating temperature of -20 °C to 150 °C) with a cumulative reactor capacity of 150 L. The facility also has a 50-liter autoclave to perform the high-pressure hydrogenation with a design pressure of 20 Bar to cater to the small-scale hydrogenation and an autoclave (500 mL to 10 L) with similar design pressure is also available for enabling gram to kilo scale.

The reactors are designed with high vacuum distillation. The facility has other downstream equipment like Pressure Nutsche Filter (PNF), rotavapor of 20 L capacity, vacuum tray dryer, and temperature control storage. The facility can cater to perform air and moisture-sensitive reactions and metal-promoted reactions.

The pilot lab consists of:

  • Jacketed cylindrical glass reactor (5 L to 50 L)
  • Huber thermal fluid circulation system (operating in temperature range of -20 °C to 150 °C)
  • Cumulative reactor with capacity of 150 L
  • 50 L autoclave with a pressure bar of 20 bar for high pressure hydrogenation
  • 50 mL to 10 L autoclave for enabling gram to kilo scale

The facility consists of following downstream equipments:

  • Pressure Nutsche filter (PNF)
  • Rotavapour of 20 L capacity
  • Vaccum tray dryer
  • Temperature control stage
  • Air and moisture sensitive reactions and metal promoted reactions

Why Aurigene Pharmaceutical Services?

Expert scientific and process engineering team

Pilot lab facilities for rapid scale-up

Dedicated steroid and HPAPI lab

High-end technology platforms comprising peptides and oligonucleotides

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