Transcript Propinquity

6 Properties of API Synthesis that Affect Yield, Delivery Date & Purity–
Propinquity
 Reduce costly GMP manufacture
 Reduce reporting of process variation/optimization
 Increase flexibility of process and sourcing
Manufacturer tendency: Less steps under cGMP
Non-GMP
GMP
SM1 + SM2
Int-1
SM3 + SM4
Int-2
Int-3
(RSM1)
Int-4
DS
Int-5
(RSM2)
Regulator tendency: More steps under cGMP
 Minimize quality risks
 Control impurities (from SM; from subsequent steps)ensure identity/purity of drug substance
 Multiple purification steps more likely to purge related substances
Legends
SM : Starting Material
Int : Intermediate
RSM : Regulatory Starting Material
DS : Drug substance
DS Salt