Quantitation of a PEGylated protein in monkey serum by UHPLC-HRMS using a surrogate disulfide-containing peptide: A new approach to bioanalysis and in vivo stability evaluation of disulfide-rich protein therapeutics

Zheng, Naiyu; Zeng, Jianing; Manney, Amy; Williams, LaKenya; Aubry, Anne‐Françoise; Voronin, K.; Buzescu, Adela; Zhang, Yan J; Allentoff, Alban J.; Xu, Carrie; Shen, Hong; Warner, W.; Arnold, Mark E.

doi:10.1016/j.aca.2016.02.017

Cited by 10 publications

(2 citation statements)

References 28 publications

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“…Zheng et al. quantified a therapeutic PEGylated protein in monkey serum by LC–MRM using a disulfide‐containing peptide as surrogate analyte as showed in Figure 6I [204]. This study provided a validated method for the analysis of the in vivo stability of disulfide‐rich proteins.…”

Section: Bioanalytical Methods For Polyethylene Glycols and Pegylatedmentioning

confidence: 99%

Recent advances in the bioanalytical methods of polyethylene glycols and PEGylated pharmaceuticals

Zhang

Song

et al. 2020

J of Separation Science

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Polyethylene glycols are synthetic polymers composed of repeating oxyethylene subunits, which have been known for non-toxic, non-immunogenic, non-antigenic, good solubility in water and therefore approved for pharmaceutical applications. Recently, attachment or amalgamation of polyethylene glycols to therapeutic small molecules, peptides, proteins, or nanoparticles has become a mature technology for the sake of improving their pharmacokinetic and pharmacological profiles, also referred to as PEGylation. By comparison, there are only a few PEGylated pharmaceuticals have been registered for further clinical trials and even less was approved for marketing. High failure rate of PEGylated pharmaceuticals in pre-clinical and clinical trials could be majorly attributed to their unclear pharmacokinetic behaviors. Therefore, the in vivo fate of the PEGylated pharmaceuticals for the various routes of administration needs to be thoroughly investigated An accurate in vivo pharmacological study thereof highly depends on the precise detection of polyethylene glycols as well as their fragments in biological matrixes. The goal of this review is to highlight the analytical methods that were developed and applied to evaluate the polyethylene glycols in pharmaceutical ingredients and excipients, which bring us closer to bridging

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Section: Bioanalytical Methods For Polyethylene Glycols and Pegylatedmentioning

confidence: 99%

Recent advances in the bioanalytical methods of polyethylene glycols and PEGylated pharmaceuticals

Zhang

Song

et al. 2020

J of Separation Science

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“…Interestingly, due to differences in diffusion properties, 1.3 µm particles seemed to be more favourable for the separation of peptides than for small molecules when using longer columns and longer gradient times [55]. Finally, the 1.6 µm SPPs have been used for the determination of PEGprotein from biological matrix following tryptic digestion [56]. For interested readers, numerous further applications can be found in brochures of manufacturers reflecting that widepore SPP technology has gained more and more interest in modern analytical laboratories.…”

Section: Spps For the Analysis Of Peptidesmentioning

confidence: 99%

New developments and possibilities of wide-pore superficially porous particle technology applied for the liquid chromatographic analysis of therapeutic proteins

Bobály

Veuthey

Guillarme

et al. 2018

Journal of Pharmaceutical and Biomedical Analysis

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This review paper discusses the success of columns packed with superficially porous particles (SPP) in liquid chromatography for the analysis of peptides and proteins. First, it summarizes the history of SPP, including the development of different SPP generations from particles of 50 μm to sub-2 μm. It also critically discusses the improved kinetic performance of SPP particles in comparison to fully porous particles. The current trends and applications of columns packed with SPPs for the analysis of peptides and proteins (including mAbs and ADC at the intact and sub-unit levels) are shown, as well. Finally, some of the potential perspectives for this technology are also described, including the radially oriented mesopores or the applicability of the technology for chiral separations.

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Sample Preparation for LC‐MS Bioanalysis of Peptides

Yuan¹

2019

Sample Preparation in LC‐MS Bioanalysis

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Quantitation of a PEGylated protein in monkey serum by UHPLC-HRMS using a surrogate disulfide-containing peptide: A new approach to bioanalysis and in vivo stability evaluation of disulfide-rich protein therapeutics

Cited by 10 publications

References 28 publications

Recent advances in the bioanalytical methods of polyethylene glycols and PEGylated pharmaceuticals

Recent advances in the bioanalytical methods of polyethylene glycols and PEGylated pharmaceuticals

New developments and possibilities of wide-pore superficially porous particle technology applied for the liquid chromatographic analysis of therapeutic proteins

Sample Preparation for LC‐MS Bioanalysis of Peptides

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