PROCESS DEVELOPMENT

  • Laminar flow hood

  • Lyophilizers

  • Microfluidizers (pilot to manufacturing scale)

  • Microfuge (refrigerated)

  • Minibeader

  • Mixers (regular, high shear, pilot scale, planetary)

  • Planetary micro mill

  • Resin grinders

  • Robotic liquid handler

  • Rotavaps

  • Sonicators

  • Soni-Sifter

  • Speedvac

  • Spheronizer (Marumerizer)

  • Spray dryers

  • Sterilizers

  • Tablet presses (single, 4- and 16-station)

  • Vacuum ovens

  • Complete sets of 1-200 liter emulsion/liposome manufacturing equipment including microfluidizers available for lease for GMP use

Process development is essential for successful transition from formulation development to scale-up and manufacture. Proper process development ensures robust and trouble-free manufacturing of drug product for regulatory, clinical and commercial activities.

Our process development equipment includes:

  • Autoclave

  • Bag-On-Valve Aerosol Filling Machine (semi-automatic)

  • Ball mill minicer (NETZSCH)

  • Blenders (V- and bin-)

  • Biosafety hoods

  • Capsule fillers (powder)

  • Capsulgel filler/sealer system (Capsugel CFS-1000)

  • Centrifuges (low speed to ultra)

  • Coaters

  • Co-mill

  • Dessicators

  • Low shear extruders, pelletizers

  • Fitzmill

  • Fluid bed processors/coaters

  • Freeze-dryers/lyophilizers

  • HDPE bottle heat sealer

  • High shear granulator

  • High shear mixer granulator (GEA)

  • High pressure extruder (Avestin)

  • Hot melt extruders with choppers

  • Homogenizers

  • Jetmill

LATITUDE’s R&D and pilot scale manufacturing capabilities include developing processes for R&D scale production and pilot scale production prior to either GMP manufacture at LATITUDE or tech transfer to a different CMO.

LATITUDE provides expert services in the areas of process development, scale-up and technology transfer for cGMP manufacturing, services and materials sourcing, test method and specifications development and CMC document preparation for FDA submissions.