2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard

WRIB bioanalysis biomarkers cell therapy gene therapy immunogenicity vaccine

Journal

Bioanalysis
ISSN: 1757-6199
Titre abrégé: Bioanalysis
Pays: England
ID NLM: 101512484

Informations de publication

Date de publication:
22 Feb 2024
Historique:
medline: 23 2 2024
pubmed: 23 2 2024
entrez: 23 2 2024
Statut: aheadofprint

Résumé

The 17

Identifiants

DOI: 10.4155/bio-2024-0024 PMID: 38389403
pubmed: 38389403
doi: 10.4155/bio-2024-0024
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Auteurs

Johanna Mora (J)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Rachel Palmer (R)

Sanofi, Cambridge, MA, USA.

Leslie Wagner (L)

US FDA, Silver Spring, MD, USA.

Bonnie Wu (B)

Janssen R&D, Spring House, PA, USA.

Michael Partridge (M)

Regeneron, Tarrytown, NY, USA.
Stoke, Cambridge, MA, USA.

Ivo Sonderegger (I)

Takeda, Opfikon, Switzerland.

John Smeraglia (J)

AstraZeneca, Cambridge, UK.

Nicoletta Bivi (N)

Eli Lilly & Company, Indianapolis, IN, USA.

Naveen Dakappagari (N)

Navigate, a Novartis Subsidiary, San Diego, CA, USA.

Sandra Diebold (S)

UK MHRA, London, UK.

Fabio Garofolo (F)

BRI Frontage, Vancouver, BC, Canada.

Christine Grimaldi (C)

Regeneron, Tarrytown, NY, USA.

Warren Kalina (W)

Pfizer, Groton, CT, USA.

John Kamerud (J)

Pfizer, Groton, CT, USA.

Sumit Kar (S)

WRIB, Toronto, ON, Canada.

Jean-Claude Marshall (JC)

Moderna, Mystic, CT, USA.

Christian Mayer (C)

Austria AGES, Vienna, Austria.

Andrew Melton (A)

BioMarin, Novato, CA, USA.

Keith Merdek (K)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Katrina Nolan (K)

Merck, West Point, PA, USA.

Serge Picard (S)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Weiping Shao (W)

AstraZeneca, Cambridge, UK.

Jessica Seitzer (J)

Intellia, Cambridge, MA, USA.

Yoichi Tanaka (Y)

Japan MHLW, Tokyo, Japan.

Omar Tounekti (O)

Health Canada, Ottawa, ON, Canada.

Adam Vigil (A)

Boehringer Ingelheim, Danbury, CT, USA.

Karl Walravens (K)

GlaxoSmithKline, Rixensart, Belgium.

Joshua Xu (J)

US FDA, Jefferson, AR, USA.
Regenxbio, Rockville, MD, USA.

Weifeng Xu (W)

Merck, West Point, PA, USA.

Yuanxin Xu (Y)

Intellia, Cambridge, MA, USA.

Lin Yang (L)

US FDA, Jefferson, AR, USA.
Regenxbio, Rockville, MD, USA.

Liang Zhu (L)

Moderna, Mystic, CT, USA.

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Robert J Kubiak (RJ)

AstraZeneca, Gaithersburg, MD, USA.

Kelly Coble (K)

Boehringer Ingelheim, Danbury, CT, USA.

Swati Gupta (S)

AbbVie, Irvine, CA, USA.

Mohsen Rajabi Abhari (MR)

US FDA, Silver Spring, MD, USA.

Susan Richards (S)

Sanofi, Cambridge, MA, USA.

Yuan Song (Y)

Genentech, South San Francisco, CA, USA.

Martin Ullmann (M)

Fresenius Kabi, Bad Homburg, Germany.

Boris Calderon (B)

Eli Lilly & Company, Indianapolis, IN, USA.

Isabelle Cludts (I)

UK MHRA, London, UK.

George R Gunn (GR)

GlaxoSmithKline, Collegeville, PA, USA.

Shalini Gupta (S)

Amgen, Thousand Oaks, CA, USA.

Akiko Ishii-Watabe (A)

Japan MHLW, Tokyo, Japan.

Mohanraj Manangeeswaran (M)

US FDA, Silver Spring, MD, USA.

Kimberly Maxfield (K)

US FDA, Silver Spring, MD, USA.

Fred McCush (F)

Pfizer, Groton, CT, USA.

Christine O'Day (C)

Seattle Genetics, Bothell, WA, USA.

Kate Peng (K)

Genentech, South San Francisco, CA, USA.

Johann Poetzl (J)

Sandoz, Oberhaching, Germany.

Michele Rasamoelisolo (M)

Sandoz, Oberhaching, Germany.

Ola M Saad (OM)

Genentech, South San Francisco, CA, USA.

Kara Scheibner (K)

US FDA, Silver Spring, MD, USA.

Sophie Shubow (S)

US FDA, Silver Spring, MD, USA.

Sam Song (S)

Takeda, Cambridge, MA, USA.

Seth Thacker (S)

US FDA, Silver Spring, MD, USA.

Classifications MeSH