A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs

Kun Yang,Ying Zhang,Robert Chou,Lai Yeung,Simon Letarte,Rong-Sheng Yang,Xuanwen Li,Maribel Beaumont,Rico Gunawan,Douglas D. Richardson,Shara Dellatore,Eric Woolf,Yang Xu

A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs

2020

Kun Yang
Ying Zhang
Robert Chou
Lai Yeung
Simon Letarte
Rong-Sheng Yang
Xuanwen Li
Maribel Beaumont
Rico Gunawan
Douglas D. Richardson
Shara Dellatore
Eric Woolf
Yang Xu

The robustness of good laboratory practice and clinical data is reliant upon a clear understanding of the bioanalytical assays. One of the most important components of ligand-binding based assays i...

Keywords:

Reproducibility
Biochemical engineering
tiered approach
Bioanalysis
Good laboratory practice
Computer science

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