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Process

Synthetic Development

Our R & D specialists have many years of expertise in developing API programs that manage the many complex issues associated with successful scale up and profitable commercialization. They utilize multiple synthetic chemistry database search systems for process development, perform high selectivity chromatography and reliably repeat complex multistage syntheses.

Equipment

  • 30 fume hoods and walk-in hoods
  • 500mL Parr Hydrogenator
  • Glass reaction vessels up to 22L capacity with magnetic or air-driven overhead stirring
  • Waters Prep LC 4000 System, 300mL/min
  • 2 bulk chromatography stations equipped with semi-automated process HPLC systems for kilo scale purification, up to 1200mL/min
  • 10 small-medium scale chromatography stations, up to 300mL/min
  • 6″ x 35″ Glass Low Pressure Static Columns
  • Assorted 1″, 1.5″, 2″, 3″ and 4″ diameter glass columns of various lengths
  • 4 Buchi rotary evaporators (volume range: up to 20L Capacity) each equipped with recirculating chiller and vacuum controller
  • 5 Heidolph rotary evaporators (volume range: up to 3L Capacity) each equipped with recirculating chiller and vacuum controller
  • Buchi rotary evaporator (volume range: up to 3L Capacity) equipped with recirculating chiller and vacuum controller
  • 3 FTS Dura-Dry MP Freeze-Dryer (20L capacity)
  • VirTis Benchtop Freeze-Dryer
  • Yamato DP-61 Vacuum Oven (7.5cf capacity)

Formulation Development

Avanti’s formulation specialists provide development services in the following areas:

  • Lyophilization cycle development for liposomal products
  • Mixing optimization for creams, pastes, or oils
  • Non-sterile lyophilized lipid formulations
  • Pre-clinical liposomal formulations

Equipment

  • Avestin EmulsiFlex-C3 w/ extruder attachment
  • Avestin EmulsiFlex-C55 w/ extruder attachment
  • FTS LyoStar II Lyophilizer (4 shelf – bulk/vial) with SMART software
  • Littleford-Day Mixer (capacity: 5L)
  • Omni TH Homogenizer (capacity: 4mL – 20mL)
  • Omni GLH Homogenizer (capacity: 50mL – 1L)
  • Multiple Avanti Sonicators
  • Multiple Avanti Mini Extruders
  • Hamilton Microlab 500 semi-automatic liquid processor
  • Brookhaven 90+ Particle Size Analyzer w/ zeta potential
  • Zeiss Axiolab A Microscope with cross polarizer optics, power supply and lamp source for fluorescence, and Infinity camera connected to PC