Michael A. Partridge

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

Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study

Sumathi Sivapalasingam, Rabih Slim, Romana Hosain et al. · The Lancet Infectious Diseases · 2018 · 84 citations

Vaccination, Vaccine Development, Vaccine Target +9

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

Shalini Gupta, Susan Richards, Lakshmi Amaravadi et al. · Bioanalysis · 2017 · 65 citations · Full text

Immunohematology, Pk Assays, White Paper +27

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

Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium

Marta Starcevic Manning, Mohamed Hassanein, Michael A. Partridge et al. · The AAPS Journal · 2022 · 27 citations · Full text