2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS ( <u>PART 3A</u> – Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity &amp; Technologies; Biotherapeutics &amp; Biosimilars Immunogenicity Assessment &amp; Clinical Relevance <u>PART 3B</u> – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell &amp; Vaccine Therapies)

Omar Tounekti, Maria Jadhav, Jessica Seitzer et al.|Bioanalysis|2025

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