Mohsen Rajabi Abhari

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 · 61 citations · Full text

Veterinary Medicine, Biomedical Sciences, Immunology +17

2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 &amp; CAR-T Immunogenicity; PCR &amp; Vaccine Assay Performance; ADA Assay Comparability &amp; Cut Point Appropriateness ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

LiNa Loo, Shannon Harris, Mark Milton et al. · Bioanalysis · 2022 · 36 citations · Full text

Medicine, Biomedical Sciences, Biotechnology +16

2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid &amp; Rare Matrices; Regulatory Inputs ( <u>Part 1A</u> – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC &amp; <u>Part 1B</u> - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Surinder Kaur, Stephen C. Alley, Matt Szapacs et al. · Bioanalysis · 2022 · 29 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +15

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( <u>Part 2A</u> –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation &amp; Innovation <u>Part 2B</u> –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Susan Spitz, Yan Zhang, Sally Fischer et al. · Bioanalysis · 2021 · 26 citations · Full text

Pharmacy, Biomedical Sciences, Immunology +16

Neutralizing Antibody Validation Testing and Reporting Harmonization

Heather Myler, João Pedras-Vasconcelos, Todd Lester et al. · The AAPS Journal · 2023 · 26 citations · Full text

Pharmacy, Immunology, Drug Approval Processes +14