Example of what happens if you don’t understand your process and have not optimized it prior to approval:

  • Controlled release line extension for existing product
  • Senior commercial leadership bullish about demand and conversion to new formulation
  • Sales and Marketing team eager to start selling the new product
  • Batch size used for phase III clinical trials manufacture too small to meet anticipated demand
  • Additional specialist manufacturing capacity needed to meet demand
  • CMO manufacturing key intermediate with little experience of commercial manufacture
What happened?
  • Process was not fully understood
  • Scale up fraught with challenges
  • Delays to capacity expansion
  • CMO could not make enough intermediate
  • Launch delayed
  • Generics entered market
  • Market opportunity missed – sales well bellow expectations