AI Article Synopsis
- * The study produced anti-siRNA polyclonal antibodies primarily targeting the N-acetylgalactosamine (GalNAc) component, which can serve as positive controls in immunogenicity assays for GalNAc-conjugated siRNAs.
- * Additionally, anti-GalNAc monoclonal antibodies showed good sensitivity and drug tolerance, indicating their potential as alternative positive controls, aiding in the development of immunogenicity assays for siRNA therapeutics.
Article Abstract
Small interfering RNA (siRNA) is gaining momentum as a therapeutic modality with six approved products. Since siRNA has the potential to elicit undesired immune responses in patients, immunogenicity assessment is required during clinical development by regulatory authorities. In this study, anti-siRNA polyclonal antibodies were generated through animal immunization. These cross-reactive polyclonal antibodies recognized mostly the N-acetylgalactosamine (GalNAc) moiety with a small fraction against sequence-independent epitopes. We demonstrate that the polyclonal antibodies can be utilized as immunogenicity assay positive controls for the same class of GalNAc-conjugated siRNAs. In addition, anti-GalNAc mAbs showed desired sensitivity and drug tolerance, supporting their use as alternative surrogate positive controls. These findings can guide positive control selection and immunogenicity assay development for GalNAc-conjugated siRNAs and other oligonucleotide therapeutics.
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| http://dx.doi.org/10.1208/s12248-024-00914-w | DOI Listing |
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