A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.
Bioanalysis
; 16(1): 5-17, 2024 Jan.
Article
en En
| MEDLINE
| ID: mdl-37991214
ABSTRACT
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.Palabras clave
PEGylated therapeutics; SARS-CoV-2 RNA vaccine anti-PEG antibodies; anti-PEG magnitude/quantification/titer; anti-PEG screening and confirmatory; individual screening; pre- and post-dose anti-PEG antibodies; preexisting anti-PEG antibodies; preexisting antibody purification; singlicate assessment in immunogenicity; solid-phase extraction and acid dissociation
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Polietilenglicoles
/
ARN Viral
Idioma:
En
Año:
2024
Tipo del documento:
Article