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

Early Phase Development and Pilot Facility

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

The services at APSL 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 & DPeptidesOligonucleotidesLipidsTox and pre-clinical studies We have 3 kilo lab facilities for scale-up Hyderabad- 20 & 50 L Bengaluru- 5, 10, 20, 50 L Hyderabad, Potent lab- 20 & 50 L Our Services Target hit identification Route scouting Phase appropriate development Standalone FFS target deliveries

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Facilities

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 Early Phase Development Services?

Expert scientific and process engineering team

Pilot lab facilities for rapid scale-up

Dedicated steroid & HPAPI lab

High-end technology platforms comprising Peptides and Oligonucleotides

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Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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