Manufacturing, Packaging and Labeling

  • Xcelodose for rapid 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)