2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (<u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)-Reference-Cited by-同舟云学术

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)

Published:2023-07 Issue:14 Volume:15 Page:773-814
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Pan Luying¹,Mora Johanna²,Walravens Karl³,Wagner Leslie⁴,Hopper Shirley⁵,Loo Lina⁶,Bettoun David⁷,Bond Sarah⁸,Dessy Francis³,Downing Sean¹,Garofolo Fabio⁹,Gupta Soumi¹⁰,Henderson Neil¹¹,Irwin Chad¹²,Ishii-Watabe Akiko¹³,Kar Sumit¹⁴,Jawa Vibha²,Joseph Julie¹²,Malvaux Ludovic³,Marshall Jean-Claude¹⁵,McDevitt Jessica²,Mohapatra Susovan¹⁶,Seitzer Jessica¹⁷,Smith Justin¹⁸,Solstad Therese¹⁹,Sugimoto Hiroshi¹,Tounekti Omar¹²,Wu Bonnie²⁰,Wu Yuling²¹,Xu Yuanxin¹⁷,Xu Joshua²²,Yamamoto Takenori¹³,Yang Lin²³,Torri Albert²⁴,Kirshner Susan⁴,Maxfield Kimberly⁴,Vasconcelos Joao Pedras⁴,Abhari Mohsen Rajabi⁴,Verthelyi Daniela⁴,Brodsky Eric⁴,Carrasco-Triguero Montserrat²⁵,Kamerud John¹⁸,Andisik Matthew²⁴,Baltrukonis Daniel¹⁸,Bivi Nicoletta²⁶,Cludts Isabelle⁵,Coble Kelly²⁷,Gorovits Boris²⁸,Gunn George R²⁹,Gupta Swati³⁰,Millner Anders Holm³¹,Joyce Alison¹⁸,Kubiak Robert J²¹,Kumar Seema³²,Liao Karen³³,Manangeeswaran Mohanraj⁴,Partridge Michael²⁴,Pine Samuel³⁴,Poetzl Johann³⁵,Rajadhyaksha Manoj³⁶,Rasamoelisolo Michele³⁷,Richards Susan³⁸,Song Yuan³⁹,Swanson Steven³⁹,Thacker Seth⁴,Wadhwa Meenu⁵,Wolf Andreas⁴⁰,Zhang Lucia¹²,Zhou Lin⁴

Affiliation:

1. Takeda, Cambridge, MA, USA

2. Bristol Myers Squibb, Lawrenceville, NJ, USA

3. GlaxoSmithKline, Rixensart, Belgium

4. US FDA, Silver Spring, MD, USA

5. UK MHRA, London, UK

6. Vertex, Boston, MA, USA

7. Larimar, Bala-Cynwyd, PA, USA

8. Alnylam, Cambridge, MA, USA

9. BRI Frontage, Vancouver, BC, Canada

10. BioMarin, Novato, CA, USA

11. AstraZeneca, Gothenburg, Sweden

12. Health Canada, Ottawa, ON, Canada

13. Japan MHLW, Tokyo, Japan

14. WRIB, Montreal, QC, Canada

15. Moderna, Mystic, CT, USA

16. Stoke, Cambridge, MA, USA

17. Intellia, Cambridge, MA, USA

18. Pfizer, Groton, CT, USA

19. Norway NoMA, Oslo, Norway

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

21. AstraZeneca, Gaithersburg, MD, USA

22. US FDA, Jefferson, AR, USA

23. REGENXBIO, Rockville, MD, USA

24. Regeneron, Tarrytown, NY, USA

25. Sangamo, Brisbane, CA, USA

26. Lilly, Indianapolis, IN, USA

27. Boehringer Ingelheim, Danbury, CT, USA

28. Sana Bio, Cambridge, MA, USA

29. GSK, Collegeville, PA, USA

30. AbbVie, Irvine, CA, USA

31. Novo Nordisk, Maaloev, Denmark

32. EMD Serono, Boston, MA, USA

33. Merck, West Point, PA, USA

34. Sanofi, Ghent, Belgium

35. Sandoz, Oberhaching, Germany

36. Alexion, New Haven, CT, USA

37. Teva, West Chester, PA, USA

38. Sanofi, Framingham, MA, USA

39. Genentech, South San Francisco, CA, USA

40. Amgen, Munich, Germany

Abstract

The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1 (Mass Spectrometry and ICH M10) and Part 2 (LBA, Biomarkers/CDx and Cytometry) are published in volume 15 of Bioanalysis, issues 16 and 15 (2023), respectively.

Publisher

Future Science Ltd

Subject

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

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2023-0135

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