Daniela Verthelyi

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Neil Henderson, Rong Zeng, Renuka Pillutla, 2018, Bioanalysis.

Scientific considerations in the review and approval of generic enoxaparin in the United States

Andre Raw, Lawrence X. Yu, Lawrence Yu, 2013, Nature Biotechnology.

Adjuvants in Primates CpG Oligodeoxynucleotides as Vaccine

Daniela Verthelyi, Dennis M. Klinman, Albert A. Gam, 2013 .

Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins.

Daniela Verthelyi, A. Rosenberg, D. Verthelyi, 2012, Journal of pharmaceutical sciences.

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

Steven Kozlowski, Theodore W Randolph, C Russell Middaugh, 2009, Journal of pharmaceutical sciences.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Eric Woolf, Akiko Ishii-Watabe, Naidong Weng, 2018, Bioanalysis.