VOLUME 15, ISSUE 14 / JULY 2023
White Paper
AUGUST 2023
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
- Luying Pan,
- Johanna Mora,
- Karl Walravens,
- Leslie Wagner,
- Shirley Hopper,
- Lina Loo,
- David Bettoun,
- Sarah Bond,
- Francis Dessy,
- Sean Downing,
- Fabio Garofolo,
- Soumi Gupta,
- Neil Henderson,
- Chad Irwin,
- Akiko Ishii-Watabe,
- Sumit Kar,
- Vibha Jawa,
- Julie Joseph,
- Ludovic Malvaux,
- Jean-Claude Marshall,
- Jessica McDevitt,
- … See all authors
- Pages:773–814
- Published Online:1 August 2023
Commentary
AUGUST 2023
Uncovering the green frontier: harnessing deep eutectic solvents for sustainable bioanalysis
- Priyanka A Shah
, - Pranav S Shrivastav ,
- Vinay S Sharma &
- Vishwajit Chavda
- Pages:815–821
- Published Online:8 August 2023
Methodology
JUNE 2023
High ionic strength dissociation assay reduces dimeric target interference in immunogenicity testing
- Alexander Pöhler,
- Cordula Jany,
- Joachim Butzer,
- Thomas Bach,
- Eugenia Opolka-Hoffmann,
- Roland F Staack &
- Gregor Jordan
- Pages:823–832
- Published Online:16 June 2023
Preliminary Communication
AUGUST 2023
A sensitive LC–MS/MS assay to quantitate free payload Aur0101 from ADC PYX-201 in rat and monkey plasma
- Feng Yin ,
- Farah Ahsan,
- Jan Pinkas,
- Biplab Das,
- Frank Wang,
- Nancy Zheng,
- David Hahn,
- Aniruddha Amrite,
- Jianwen Feng,
- Diana Adhikari,
- Jack Sikora,
- Elizabeth Shaheen &
- Shawn Harriman
- Pages:833–843
- Published Online:16 August 2023
Research Article
JUNE 2023
Volumetric absorptive microsampling as an effective microsampling technique for LC–MS/MS bioanalysis of biomarkers in drug discovery
- Unnati Kapadnis,
- Chuck Locuson,
- Heidi Okamura,
- Gianluca De Rienzo,
- Cece Cotter,
- Dongwei Zhu,
- Rohini Narayanaswami,
- Jose Castro-Perez,
- Punit Marathe &
- Wen-Chu Yang
- Pages:845–859
- Published Online:12 June 2023