Publications

The Potential for Ion Mobility in Pharmaceutical and Clinical Analyses

Author(s)

Kelly L Wormwood, Liulin Deng, Ahmed M Hamid, Daniel DeBord, Laura Maxon.

Abstract

Pharmaceutical companies must maintain the same glycan profile throughout the whole development process, and any company hoping to make a biosimilar must also mimic this profile, as the FDA states that differences in glycosylation lead to the drug no longer being biologically equivalent. This paper explores how MOBILion's SLIM-based HRIM is perfectly suited for pharmaceutical and clinical analyses.

Customer Intro

Problem

Solution

Conclusions

Abstract

The paper, published in Analytical Chemistry, concludes:

MOBILion's ion mobility technology shows potential in two specific areas: glycosylation monitoring of biological drugs and vitamin D analysis, representing its potential in both the pharmaceutical and clinical industries.
Accurately, reproducibly, and quickly monitoring the glycosylation of biological drugs throughout all stages of drug development and manufacturing is crucial. Several critical quality attributes (CQAs) have been identified specifically for glycosylation, but the sample preparation and analytical methods for monitoring these CQAs are less defined.
Ion mobility provides separation of isobaric molecules, which can be crucial in diagnostic tests or in identifying different drugs. It also offers an additional point of measurement (CCS) based on the shape/size of the molecule, providing further molecular identification confirmation and additional structural information.
MOBILion conducted an initial study on 25-hydroxy vitamin D2 and 25-hydroxy vitamin D3 using SLIM-MS to evaluate its suitability for analyzing these specific vitamin D metabolites. Two peaks were present for each metabolite, both fully resolved, likely corresponding to the most stable "closed" forms.

Results