A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies : pre- and post-dose of PEGylated therapies
Aim: 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. Materials & methods: 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. Results & conclusion: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 2023 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Bioanalysis - 16(2023), 1 vom: 18. Jan., Seite 5-17 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Jyamubandi, Issa [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.12.2023 Date Revised 16.12.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.4155/bio-2023-0196 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364824956 |
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| 245 | 1 | 2 | |a A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies |b pre- and post-dose of PEGylated therapies |
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| 500 | |a Date Completed 16.12.2023 | ||
| 500 | |a Date Revised 16.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Aim: 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. Materials & methods: 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. Results & conclusion: 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Review | |
| 650 | 4 | |a PEGylated therapeutics | |
| 650 | 4 | |a SARS-CoV-2 RNA vaccine anti-PEG antibodies | |
| 650 | 4 | |a anti-PEG magnitude/quantification/titer | |
| 650 | 4 | |a anti-PEG screening and confirmatory | |
| 650 | 4 | |a individual screening | |
| 650 | 4 | |a pre- and post-dose anti-PEG antibodies | |
| 650 | 4 | |a preexisting anti-PEG antibodies | |
| 650 | 4 | |a preexisting antibody purification | |
| 650 | 4 | |a singlicate assessment in immunogenicity | |
| 650 | 4 | |a solid-phase extraction and acid dissociation | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a Polyethylene Glycols |2 NLM | |
| 650 | 7 | |a 3WJQ0SDW1A |2 NLM | |
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| 700 | 1 | |a Kaur, Jyotsna |e verfasserin |4 aut | |
| 700 | 1 | |a Sylvester, Alen |e verfasserin |4 aut | |
| 700 | 1 | |a Hughes, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Sophia |e verfasserin |4 aut | |
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