A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic

Cohen, Joseph R.; Brych, Stephen R.; Prabhu, Siddharth; Bi, Vivian; Elbaradei, Ahmed; Tokuda, Joshua M.; Xiang, Cathie; Hokom, Martha; Cui, Xiaohong; Ly, Claudia; Amos, Nathan; Sun, Jilin; Calamba, Dominador; Herskovitz, Jonathan; Capili, Allyson; Nourbakhsh, Kimya; Merlo, Anthony; Carreon, Julia; Wypych, Jette; Narhi, Linda O.; Jawa, Vibha; Joubert, Marisa K.

doi:10.1007/s11095-024-03678-2

Pharm Res

2024

DOI: 10.1007/s11095-024-03678-2

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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic

Joseph R. Cohen,

Stephen R. Brych,

Siddharth Prabhu

et al.

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Cited by 3 publications

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Aggregation of therapeutic monoclonal antibodies due to thermal and air/liquid interfacial agitation stress: Occurrence, stability assessment strategies, aggregation mechanism, influencing factors, and ways to enhance stability

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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic

Cited by 3 publications

References 103 publications

Aggregation of therapeutic monoclonal antibodies due to thermal and air/liquid interfacial agitation stress: Occurrence, stability assessment strategies, aggregation mechanism, influencing factors, and ways to enhance stability

Aggregation of therapeutic monoclonal antibodies due to thermal and air/liquid interfacial agitation stress: Occurrence, stability assessment strategies, aggregation mechanism, influencing factors, and ways to enhance stability

Immunogenicity risk assessment of empty capsids present in adeno-associated viral vectors using predictive innate immune responses

Experimental validation of a parenteral permitted daily exposure value for cleaning-induced degradants from recombinant therapeutic proteins with in vitro immunogenicity assays

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