Bart Corsaro

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Steven P. Piccoli, Devangi Mehta, Alessandra Vitaliti et al. · Bioanalysis · 2019 · 92 citations · Full text

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene &amp; Cell Therapy and Vaccine Assays)

Bart Corsaro, Tong‐Yuan Yang, Rocio Murphy et al. · Bioanalysis · 2021 · 60 citations