What Does Microchip CE + QTOF MS Do For Oligo Analysis?

With a renewed and growing interest in therapeutic oligonucleotides (oligos) across the pharmaceutical industry, the requirements to characterize synthetic oligos have increasingly become more stringent to ensure safety and efficacy of the therapeutics. Two critical aspects include:

 

1. Characterization of the active pharmaceutical ingredient (API) and related substances including synthetic or process-related impurities.

2. Determination of in vivo exposure and clearance.

 

Aditya will highlight the characterization of oligo API and impurities utilizing microchip capillary electrophoresis (ZipChip) for separation of oligos, followed by high resolution mass spectrometry. Remco will highlight the use of the ZenoTOF 7600 for quantitative bioanalysis of several oligonucleotides down to levels as low as 1 ng/mL. Furthermore, high resolution analysis also reveals also reveals the very low level presence of impurities and modifications.

 

At the conclusion of this session, the participant will be able to: