2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (

Cell- and Tissue-Based Therapy Flow Cytometry Genetic Therapy Humans Quality Control Real-Time Polymerase Chain Reaction Receptors, Chimeric Antigen / analysis United States United States Food and Drug Administration Vaccines / analysis
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:
Mar 2021
Historique:
pubmed: 4 2 2021
medline: 30 11 2021
entrez: 3 2 2021
Statut: ppublish

Résumé

The 14

Identifiants

DOI: 10.4155/bio-2021-0007 PMID: 33533276
pubmed: 33533276
doi: 10.4155/bio-2021-0007
doi:

Substances chimiques

Receptors, Chimeric Antigen 0
Vaccines 0

Types de publication

Journal Article Validation Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

415-463

Auteurs

Bart Corsaro (B)

GlaxoSmithKline, Rockville, MD, USA.

Tong-Yuan Yang (TY)

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

Rocio Murphy (R)

Merck, West Point, PA, USA.

Ivo Sonderegger (I)

Takeda, Opfikon, Switzerland.

Andrew Exley (A)

UK MHRA, London, UK.

Sylvie Bertholet (S)

GlaxoSmithKline, Rockville, MD, USA.

Naveen Dakappagari (N)

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

Francis Dessy (F)

GlaxoSmithKline, Rixensart, Belgium.

Fabio Garofolo (F)

BRI, Vancouver, BC, Canada.

Lisa Kierstead (L)

PPD, Wayne, PA, USA.

Holger Koch (H)

Takeda, Opfikon, Switzerland.

Ghanashyam Sarikonda (G)

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

Natasha Savoie (N)

CFABS, Montreal, QC, Canada.

Richard Siggers (R)

Health Canada, Ottawa, ON, Canada.

Therese Solstad (T)

Norwegian Medicines Agency, Oslo, Norway.

Yanmei Lu (Y)

Sangamo Therapeutics, Brisbane, CA, USA.

Mark Milton (M)

Novartis, Cambridge, MA, USA.

Jean-Claude Marshall (JC)

Pfizer, Groton, CT, USA.

Jason DelCarpini (J)

bluebird bio, Cambridge, MA, USA.

Boris Gorovits (B)

Pfizer, Andover, MA, USA.

Swati Gupta (S)

Abbvie, Irvine, CA, USA.

Lynne Jesaitis (L)

BioMarin, Novato, CA, USA.

John Kamerud (J)

Pfizer, Andover, MA, USA.

Arno Kromminga (A)

BioAgilytix, Hamburg, Germany.

Anna Ma (A)

CRISPR Therapeutics, Cambridge, MA, USA.

Jim McNally (J)

BioAgilytix, Durham, NC, USA.

Haoheng Yan (H)

US FDA, Silver Spring, MD, USA.

Bonnie Wu (B)

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

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Susan Kirshner (S)

US FDA, Silver Spring, MD, USA.

Joao Pedras-Vasconcelos (J)

US FDA, Silver Spring, MD, USA.

Manoj Rajadhyaksha (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Roland F Staack (RF)

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

Elana Cherry (E)

Health Canada, Ottawa, ON, Canada.

Isabelle Cludts (I)

UK MHRA-NIBSC, London, UK.

Madeleine Dahlbäck (M)

Novo Nordisk, Maaloev, Denmark.

George R Gunn (GR)

GlaxoSmithKline, Collegeville, PA, USA.

Akiko Ishii-Watabe (A)

Japan MHLW-NIHS, Tokyo, Japan.

Vibha Jawa (V)

Merck, Kenilworth, NJ, USA.

Robert Kubiak (R)

AstraZeneca, Gaithersburg, MD, USA.

Michael Partridge (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Marco Petrillo (M)

Biogen, Cambridge, MA, USA.

Samuel O Pine (SO)

Ablynx, Zwijnaarde, Belgium.

Johann Poetzl (J)

Hexal AG, Oberhaching, Germany.

Sam Song (S)

Takeda, Cambridge, MA, USA.

Chris Stebbins (C)

Immunologix Labs, Tampa, FL, USA.

Yuling Wu (Y)

AstraZeneca, Gaithersburg, MD, USA.

Lucia Zhang (L)

Health Canada, Ottawa, ON, Canada.

Sumit Kar (S)

CFABS, Montreal, QC, Canada.

Meina Liang (M)

AstraZeneca, South San Francisco, CA, USA.

Mohsen Rajabi Abhari (MR)

US FDA, Silver Spring, MD, USA.

Becky Schweighardt (B)

BioMarin, Novato, CA, USA.

Kay Stubenrauch (K)

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

Yuanxin Xu (Y)

Intellia Therapeutics, Cambridge, MA, USA.

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Classifications MeSH

questionsmedicales.fr › Thérapeutique › Biothérapie › Thérapie cellulaire et tissulaire › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytophotométrie › Cytométrie en flux › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Génie génétique › Thérapie génétique › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Technologie, industrie et agriculture › Technologie › Contrôle de qualité › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques d'amplification d'acides nucléiques › Réaction de polymérisation en chaîne › Réaction de polymérisation en chaine en temps réel › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Récepteurs cytoplasmiques et nucléaires › Récepteurs chimériques pour l'antigène › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › 2020 White Paper on Recent Issues in...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › 2020 White Paper on Recent Issues in...