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C. Grimaldi

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Open access Aug 2026

Structural insights into antibody-antibody interactions in sandwich ELISA: implications for assay development and performance.

The enzyme-linked immunosorbent assay (ELISA) is a widely utilized immunoassay technique in biopharmaceutical drug development due to its high sensitivity and specificity. Optimizing assay performance necessitates addressing challenges that arise during method development, particularly the selection of compatible monoc...

Yue Su, Bo Zhao, Youmi Moon et al. · 0 citations
Review Open access Sep 2026

Immunogenicity in Approved Adeno-Associated Virus-Based Gene Therapies: A Framework for a Tailored Assessment Strategy

A comprehensive review of the nonclinical and clinical immunogenicity data from nine AAV-based GTPs approved by the US Food and Drug Administration and European Medicines Agency between 2017 and early 2026 offers science-based recommendations to inform the future development of GTPs.

Ching-Ha Lai, Susan C. Irvin, L. Salazar-Fontana et al. · 0 citations

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