An Industry Perspective Approach and Control Strategy for Implementation of Ready-to-Use Cells in Bioassays: Survey Outcome And Recommendations-Reference-Cited by-同舟云学术

An Industry Perspective Approach and Control Strategy for Implementation of Ready-to-Use Cells in Bioassays: Survey Outcome And Recommendations

Published:2024-04 Issue:4 Volume:76 Page:135-144
ISSN:0736-6205
Container-title:BioTechniques
language:en
Short-container-title:BioTechniques

Author:

White John R¹^ORCID,Ahmed Sammina²^ORCID,Amstrup Jan³^ORCID,Bennington Petra⁴^ORCID,Cheng Zhijie Jey⁵^ORCID,Day Peter⁶^ORCID,Haenssen Keneshia K⁷^ORCID,Kozminsky-Atias Adi⁸^ORCID,Martinez Eva⁹^ORCID,Ong Esther HQ¹⁰^ORCID,Qahwash Isam⁵^ORCID,Stokes Elaine SE¹¹^ORCID,Wang Jenny¹²^ORCID

Affiliation:

1. Analytical Development, GlaxoSmithKline Research & Development, 1250 S Collegeville Road, Collegeville, PA19426, USA

2. Global Biologics Technical Development (Analytical Development), Lonza Biologics plc, 228 Bath Road, Slough, SL1 4DX, UK

3. Chemistry, Manufacturing & Controls Bioanalysis, Novo Nordisk, Novo Nordisk Park, Maloev, 2760, Denmark

4. Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ07033, USA

5. Biologics Development, Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ08903, USA

6. Genentech, Inc., 1 DNA Way, South San Francisco, CA94080, USA

7. Antibody Pharmaceutical Development, Arcus Biosciences, Inc., 3928 Point Eden Way, Hayward, CA94545, USA

8. Ferring Be’er Tuvia Industrial Zone, Kiryat Malachi, 8310402, Israel

9. UCB Pharma, Chemin du Foriest, Braine-l’Alleud, 1420, Belgium

10. Nonclinical Pharmacology, Fresenius Kabi SwissBioSim GmbH, Terre Bonne Business Park, Route de Crassier 23-A3, Eysins, CH1262, Switzerland

11. BioPhorum Operations Group, BioPhorum, The Gridiron Building, 1 Pancras Square, London, N1C 4AG, UK

12. Gilead Sciences, Inc., 4010 Ocean Ranch Blvd, Oceanside, CA 92056, USA

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.2144/btn-2023-0086

Reference11 articles.

1. Turning Cells into Reagents: The Preparation of Assay Ready Cells for Routine Use in Bioassays

2. Development of a robust reporter-based ADCC assay with frozen, thaw-and-use cells to measure Fc effector function of therapeutic antibodies

3. Increased consistency and efficiency in routine potency testing by bioassay with direct use of cryopreserved (ready-to-plate) cells

4. A method for the production of cryopreserved aliquots of antigen-preloaded, mature dendritic cells ready for clinical use

5. Thaw-and-use target cells pre-labeled with calcein AM for antibody-dependent cell-mediated cytotoxicity assays