ANALYTICAL METHOD FOR FAB AND FAB' MOLECULES

摘要

A method of measuring acidic species generated by degradation of a Fab or Fab' component of a Fab-PEG or a Fab'-PEG comprising the steps of: a) cleaving the PEG and linker from the Fab-PEG or Fab'-PEG with an enzyme; b) optionally separating the PEG and linker generated in step a) from the Fab or Fab', to provide a Fab or Fab'; and c) quantitatively analyzing acidic species associated with the cleaved Fab or Fab' and/or the cleaved PEG.