Manufacturing, Packaging and Labeling

  • Fluid bed granulator equipped with multiple inserts for granulating, drying and Wurster multi-particulate coating
  • High shear granulation
  • Conical milling for de-lumping materials and granulations
  • Instrumented tablet press equipped with de-dusting and metal detection
  • Tablet coating system equipped with multiple size perforated coating pans
  • Xcelodose for high accuracy powder in capsule filling
  • cGMP drug product manufacturing suite and bottling/labeling line
  • cGMP Class 10,000 Manufacturing Suite/Class 100,000 Packaging Suite
  • Late stage development
  • Strong track record of technology transfer of manufacturing processes to late stage cGMP manufacturers
  • Quality by Design (QbD) process evaluation using FMEA model
  • Determination of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA)
  • Statistical Design of Experiments (DOE)