OUR FACILITY & EQUIPMENT

Ascendia’s facility is located in North Brunswick, NJ. We have formulation development and analytical testing laboratories in which we conduct our prototype screening, product development, physical property characterization activities, method development, method validation and stability testing.

Ascendia has Class 10,000 (ISO 7) and Class 100 (ISO 5) cleanrooms for conducting cGMP manufacture of sterile injectable products, and Class 10,000 (ISO 7) manufacturing suites for production of oral dosage forms. Ascendia is qualified to produce Phase I/II clinical trial materials – both for formulations developed by Ascendia and for formulations transferred to Ascendia. Ascendia also has self-contained isolators for use with high potency compounds and/or aseptic processing.

We have a wide variety of equipment for producing pharmaceutical formulations:

• Fluid-bed granulation and coating
• High shear granulation
• Microfluidizer
• Roller compaction
• Conical mill
• Tablet compression
• Capsule filling
• Spray dryer
• High pressure homogenizer
• Covaris sonicator
• Hot-melt extrusion
• Solvent evaporation
• Nano-particle bead-milling
• Lyophilization (freeze-drying)
• Autoclave
• Isolators for potent compounds
  
  

Our analytical instrumentation for testing pharmaceutical formulations:

• HPLC and UPLC (Empower 3)
• GC
• LCMS
• FTIR / ATR
• UV/Vis spectrophotometry
• Karl Fischer moisture determination
• USP Dissolution
• UV (fiber optic) Dissolution
• Differential scanning calorimetry (DSC and mDSC)
• Particle size distribution analysis
• Nanozetasizer
• NMR and XRPD
• HPLC-CAD & HPLC-MS/MS
• Total Organic Carbon (TOC) Analyzer
• Polarized light microscopy
• Charge Aerosol Detector (CAD)
• Finished dosage form testing: density, hardness; friability, disintegration, viscosity, etc.
• ICH stability chambers