Development of the Late-Phase Manufacturing Process of ZPL389: Control of Process Impurities by Enhanced Process Knowledge

Ernesto Santandrea,Christine Waldraff,Gilles Gerber,Maël Moreau,Pascal Beney

Development of the Late-Phase Manufacturing Process of ZPL389: Control of Process Impurities by Enhanced Process Knowledge

2021

Ernesto Santandrea
Christine Waldraff
Gilles Gerber
Maël Moreau
Pascal Beney

The development of the late-phase manufacturing process of the drug candidate ZPL389 and the strategies for the control of impurities are outlined in detail. Selective salt formation at several sta...

Keywords:

Process engineering
Impurity
drug candidate
salt formation
Materials science
Nucleophilic aromatic substitution
process knowledge
process
late phase
manufacturing process

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