GMP BATCH RELEASE TESTING FOR OLIGONUCLEOTIDES

GMP clinical batch release of oligonucleotides requires identity testing by a combination of two or more analytical procedures to overcome inherent specificity limitations of individual procedures. This case study from Intertek's Dr Jo-Anne Riley, provides a snapshot of how high resolution accurate mass with tandem mass spectrometry provides oligonucleotide identity confirmation by intact accurate mass measurement and sequence confirmation.