A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies

Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys and Krystexxa withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies...

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Bibliographic Details
Published in:	Bioanalysis Vol. 16; no. 1; p. 5
Main Authors:	Jyamubandi, Issa, Aamir, Aanya, Kaur, Jyotsna, Sylvester, Alen, Hughes, Richard, Li, Sophia
Format:	Journal Article
Language:	English
Published:	England 01-01-2024
Subjects:	Polyethylene Glycols - chemistry RNA, Viral SARS-CoV-2 RNA vaccine anti-PEG antibodies individual screening PEGylated therapeutics singlicate assessment in immunogenicity anti-PEG screening and confirmatory pre- and post-dose anti-PEG antibodies preexisting antibody purification anti-PEG magnitude/quantification/titer solid-phase extraction and acid dissociation preexisting anti-PEG antibodies
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Summary:	Preexisting anti-polyethylene glycol (PEG) antibodies (APAs) may affect the efficacy and safety of PEGylated compounds. Omontys and Krystexxa withdrawal and SARS-CoV-2 RNA vaccine anaphylaxis have all been linked to APAs. This project aimed to develop and validate a method to detect total antibodies against PEG, pre- and post-dose. The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid-phase extraction and acid dissociation assay coupled with the Meso Scale Discovery platform. Using singlicate analysis, the method was validated to successfully detect APA pre- and post-dose, with a crucial aspect of the method being the preparation of an appropriate negative control.
ISSN:	1757-6199
DOI:	10.4155/bio-2023-0196