METHODS FOR DETERMINING ACTIVE INGREDIENTS IN PRO-DRUG PEG PROTEIN CONJUGATES WITH RELEASABLE PEG REAGENTS (IN VITRO DE-PEGYLATION)

摘要

The present invention relates to an in vitro method of releasing a reversibly-linked water-soluble polymer from a protein modified by the water-soluble polymer comprising the step of incubating the protein under conditions effective to release the water-soluble polymer, wherein the conditions comprise increasing free amine concentration of a buffer comprising the protein to a free amine concentration effective to release the water-soluble polymer.