Application of 6‐aminoquinolyl‐<i>N</i>‐hydroxysuccinimidyl carbamate derivatization for enhanced peptide mapping analysis of non‐biological complex drug glatiramer acetate using liquid chromatography/electrospray ionization collision‐induced dissociation high‐resolution mass spectrometry

Mesonzhnik, Natalia V.; Kuznetsov, Roman M.; Bochkareva, N. L.; Appolonova, Svetlana A.

doi:10.1002/rcm.8748

Cited by 1 publication

(1 citation statement)

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“…Other members of this class of medicines are polymeric drugs (other than PEGylated protein therapeutics), nanoparticles, liposomes and drug nanocrystals. Currently, there very few examples of using MS‐based methods for the analysis of such compounds (Mesonzhnik et al, 2020), and none of the published work examines these products at the intact‐entity level. However, several MS‐based techniques covered in this review (such as CDMS and GEMMA) are capable of generating meaningful information not only on intact nanoparticles (Weiss, Pogan, et al, 2019; Weiss et al, 2020) but also on more complex nano‐objects, such as liposomes (Weiss et al, 2016; Weiss, Wieland, et al, 2019) and exosomes (Brown et al, 2020).…”

Section: Applicationsmentioning

confidence: 99%

Mass spectrometry‐based methods to characterize highly heterogeneous biopharmaceuticals, vaccines, and nonbiological complex drugs at the intact‐mass level

Kaltashov

Ivanov

Yang

2022

Mass Spectrometry Reviews

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The intact‐mass MS measurements are becoming increasingly popular in characterization of a range of biopolymers, especially those of interest to biopharmaceutical industry. However, as the complexity of protein therapeutics and other macromolecular medicines increases, the new challenges arise, one of which is the high levels of structural heterogeneity that are frequently exhibited by such products. The very notion of the molecular mass measurement loses its clear and intuitive meaning when applied to an extremely heterogenous system that cannot be characterized by a unique mass, but instead requires that a mass distribution be considered. Furthermore, convoluted mass distributions frequently give rise to unresolved ionic signal in mass spectra, from which little‐to‐none meaningful information can be extracted using standard approaches that work well for homogeneous systems. However, a range of technological advances made in the last decade, such as the hyphenation of intact‐mass MS measurements with front‐end separations, better integration of ion mobility in MS workflows, development of an impressive arsenal of gas‐phase ion chemistry tools to supplement MS methods, as well as the revival of the charge detection MS and its triumphant entry into the field of bioanalysis already made impressive contributions towards addressing the structural heterogeneity challenge. An overview of these techniques is accompanied by critical analysis of the strengths and weaknesses of different approaches, and a brief overview of their applications to specific classes of biopharmaceutical products, vaccines, and nonbiological complex drugs.

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