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Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety.
Ballman, Kimberly K; Peek, Victoria L; Sloan, John H; Li, Jingling; Konrad, Robert J; Wen, Yi.
Afiliación
  • Ballman KK; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
  • Peek VL; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
  • Sloan JH; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
  • Li J; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
  • Konrad RJ; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
  • Wen Y; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA. wen_yi1@lilly.com.
AAPS J ; 26(3): 41, 2024 04 03.
Article en En | MEDLINE | ID: mdl-38570436
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oligonucleótidos / Acetilgalactosamina Límite: Animals / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oligonucleótidos / Acetilgalactosamina Límite: Animals / Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos