2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles

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:
Aug 2023
Historique:
medline: 7 9 2023
pubmed: 16 8 2023
entrez: 16 8 2023
Statut: ppublish

Résumé

The 16

Identifiants

pubmed: 37584363
doi: 10.4155/bio-2023-0151
doi:

Substances chimiques

Ligands 0
Biomarkers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

861-903

Auteurs

Giane Sumner (G)

Regeneron, Tarrytown, NY, USA.

Steve Keller (S)

AbbVie, South San Francisco, CA, USA.

James Huleatt (J)

Sanofi Pasteur, Swiftwater, PA, USA.

Roland F Staack (RF)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Leslie Wagner (L)

US FDA, Silver Spring, MD, USA.

Mitra Azadeh (M)

Alkermes, Waltham, MA, USA.

Abbas Bandukwala (A)

US FDA, Silver Spring, MD, USA.

Liching Cao (L)

Sangamo, Brisbane, CA, USA.

Xiulian Du (X)

US FDA, Silver Spring, MD, USA.

Gabriela Franco Salinas (GF)

Janssen, Leiden, South Holland, Netherlands.

Fabio Garofolo (F)

BRI Frontage, Vancouver, BC, Canada.

Shannon Harris (S)

HilleVax, Cambridge, MA, USA.

Shirley Hopper (S)

UK MHRA, London, UK.

Chad Irwin (C)

Health Canada, Ottawa, ON, Canada.

Qin Ji (Q)

AbbVie, North Chicago, IL, USA.

Julie Joseph (J)

Health Canada, Ottawa, ON, Canada.

Lindsay King (L)

Pfizer, Cambridge, MA, USA.

Arvind Kinhikar (A)

Novartis, Cambridge, MA, USA.

Yang Lu (Y)

US FDA, Silver Spring, MD, USA.

Rosa Luo (R)

Crinetics, San Diego, CA, USA.

Omar Mabrouk (O)

Biogen, Cambridge, MA, USA.

Ludovic Malvaux (L)

GSK Vaccines, Rixensart, Belgium.

Jean-Claude Marshall (JC)

Moderna, Cambridge, MA, USA.

Kristina McGuire (K)

Regeneron, Tarrytown, NY, USA.

Vincent Mikol (V)

Sanofi, Vitry-sur-Seine, France.

Robert Neely (R)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Xiazi Qiu (X)

WRIB, Montreal, QC, Canada.

Yoshiro Saito (Y)

Japan MHLW, Tokyo, Japan.

Bruno Salaun (B)

GSK Vaccines, Rixensart, Belgium.

Ingrid Scully (I)

Pfizer, Pearl River, NY, USA.

John Smeraglia (J)

UCB, Braine-l'Alleud, Wallonia, Belgium.

Therese Solstad (T)

Norway NoMA, Oslo, Norway.

Jeroen Stoop (J)

Janssen, Leiden, South Holland, Netherlands.

Huaping Tang (H)

GlaxoSmithKline, Collegeville, PA, USA.

Priscila Teixeira (P)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Yixin Wang (Y)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Mike Wright (M)

GlaxoSmithKline, Stevenage, UK.

Luis Mendez (L)

Merck, Kenilworth, NJ, USA.

Chris Beaver (C)

Syneos Health, Toronto, ON, Canada.

Jacqueline Eacret (J)

Merck, West Point, PA, USA.

Amelia Au-Yeung (A)

Genentech, South San Francisco, CA, USA.

Vilma Decman (V)

GlaxoSmithKline, Philadelphia, PA, USA.

Francis Dessy (F)

GSK Vaccines, Rixensart, Belgium.

Steven Eck (S)

AstraZeneca, Gaithersburg, MD, USA.

Polina Goihberg (P)

Pfizer, Andover, MA, USA.

Enrique Gomez Alcaide (EG)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Christele Gonneau (C)

Labcorp, Meyrin, Switzerland.

Katharine Grugan (K)

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

Michael Nathan Hedrick (MN)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Sumit Kar (S)

WRIB, Montreal, QC, Canada.

Sarita Sehra (S)

Incyte, Wilmington, DE, USA.

Erin Stevens (E)

Pfizer, Groton, CT, USA.

Chad Stevens (C)

Pfizer, Andover, MA, USA.

Yongliang Sun (Y)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Fred McCush (F)

Pfizer, Groton, CT, USA.

LaKenya Williams (L)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Sally Fischer (S)

Genentech, South San Francisco, CA, USA.

Bonnie Wu (B)

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

Gregor Jordan (G)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Chris Burns (C)

UK MHRA, London, UK.

Isabelle Cludts (I)

UK MHRA, London, UK.

Kelly Coble (K)

Boehringer Ingelheim, Ridgefield, CT, USA.

Christine Grimaldi (C)

Regeneron, Tarrytown, NY, USA.

Neil Henderson (N)

Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Alison Joyce (A)

Pfizer, Groveland, MA, USA.

Gregor Lotz (G)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Yanmei Lu (Y)

Sangamo, Brisbane, CA, USA.

Linlin Luo (L)

Merck, West Point, PA, USA.

Florian Neff (F)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Gizette Sperinde (G)

Genentech, South San Francisco, CA, USA.

Kay-Gunnar Stubenrauch (KG)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Yuting Wang (Y)

WRIB, Montreal, QC, Canada.

Mark Ware (M)

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

Weifeng Xu (W)

Merck, West Point, PA, USA.

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Classifications MeSH