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 (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

Author:

Corsaro Bart1,Yang Tong-yuan2,Murphy Rocio3,Sonderegger Ivo4,Exley Andrew5,Bertholet Sylvie1,Dakappagari Naveen6,Dessy Francis7,Garofolo Fabio8,Kierstead Lisa9,Koch Holger4,Sarikonda Ghanashyam6,Savoie Natasha10,Siggers Richard11,Solstad Therese12,Lu Yanmei13,Milton Mark14,Marshall Jean-Claude15,DelCarpini Jason16,Gorovits Boris17,Gupta Swati18,Jesaitis Lynne19,Kamerud John17,Kromminga Arno20,Ma Anna21,McNally Jim22,Yan Haoheng23,Wu Bonnie2,Verthelyi Daniela23,Kirshner Susan23,Pedras-Vasconcelos Joao23,Rajadhyaksha Manoj24,Staack Roland F.25,Cherry Elana11,Cludts Isabelle26,Dahlbäck Madeleine27,Gunn George R.28,Ishii-Watabe Akiko29,Jawa Vibha30,Kubiak Robert31,Partridge Michael24,Petrillo Marco32,Pine Samuel O.33,Poetzl Johann34,Song Sam35,Stebbins Chris36,Wu Yuling31,Zhang Lucia11,Kar Sumit10,Liang Meina37,Abhari Mohsen Rajabi23,Schweighardt Becky19,Stubenrauch Kay25,Xu Yuanxin38

Affiliation:

1. GlaxoSmithKline, Rockville, MD, USA

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

3. Merck, West Point, PA, USA

4. Takeda, Opfikon, Switzerland

5. UK MHRA, London, UK

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

7. GlaxoSmithKline, Rixensart, Belgium

8. BRI, Vancouver, BC, Canada

9. PPD, Wayne, PA, USA

10. CFABS, Montreal, QC, Canada

11. Health Canada, Ottawa, ON, Canada

12. Norwegian Medicines Agency, Oslo, Norway

13. Sangamo Therapeutics, Brisbane, CA, USA

14. Novartis, Cambridge, MA, USA

15. Pfizer, Groton, CT, USA

16. bluebird bio, Cambridge, MA, USA

17. Pfizer, Andover, MA, USA

18. Abbvie, Irvine, CA, USA

19. BioMarin, Novato, CA, USA

20. BioAgilytix, Hamburg, Germany

21. CRISPR Therapeutics, Cambridge, MA, USA

22. BioAgilytix, Durham, NC, USA

23. US FDA, Silver Spring, MD, USA

24. Regeneron Pharmaceuticals, Tarrytown, NY, USA

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

26. UK MHRA-NIBSC, London, UK

27. Novo Nordisk, Maaloev, Denmark

28. GlaxoSmithKline, Collegeville, PA, USA

29. Japan MHLW-NIHS, Tokyo, Japan

30. Merck, Kenilworth, NJ, USA

31. AstraZeneca, Gaithersburg, MD, USA

32. Biogen, Cambridge, MA, USA

33. Ablynx, Zwijnaarde, Belgium

34. Hexal AG, Oberhaching, Germany

35. Takeda, Cambridge, MA, USA

36. Immunologix Labs, Tampa, FL, USA

37. AstraZeneca, South San Francisco, CA, USA

38. Intellia Therapeutics, Cambridge, MA, USA

Abstract

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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