2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3– Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

Author:

Loo Lina1,Harris Shannon2,Milton Mark3,Meena 4,Lembke Wibke5,Berisha Flora6,Bertholet Sylvie7,Dessy Francis8,Dodge Robert9,Fang Xiaodong10,Fiscella Michele11,Garofolo Fabio12,Gorovits Boris13,Gupta Soumi14,Jawa Vibha15,Ishii-Watabe Akiko16,Long Brian14,Lu Yanmei17,Mack Timothy15,McGuire Kristina18,Nolan Katrina19,Pan Luying20,Potthoff Bernd21,Purushothama Shobha22,Smith Dean23,Solstad Therese24,Sonderegger Ivo25,Taddeo Frank20,Tangri Shabnam26,Wagner Leslie27,Wu Bonnie6,Xu Yuanxin28,Kirshner Susan27,Verthelyi Daniela27,Yan Haoheng27,Maxfield Kimberly27,Pedras-Vasconcelos Joao27,Abhari Mohsen Rajabi27,Gupta Swati29,Wu Yuling30,Rajadhyaksha Manoj31,Andisik Matthew18,Baltrukonis Daniel32,Cherry Elana23,Cludts Isabelle33,Gunn George34,Millner Anders Holm35,Jordan Gregor36,Kar Sumit22,Kubiak Robert30,Lotz Gregor P36,Palmer Rachel37,Peng Kun38,Poetzl Johann39,Richards Susan37,Savoie Natasha22,Staack Roland F36,Stubenrauch Kay36,Wadhwa Meenu33,Waxenecker Günter40,Yang Tong-Yuan6,Zhang Lucia23

Affiliation:

1. Vertex, Boston, MA

2. HilleVax, Cambridge, MA, USA

3. Novartis, Cambridge, MA, USA

4. Stoke, Cambridge, MA, USA

5. UCB Farchim SA, Bulle, Switzerland

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

7. GlaxoSmithKline Vaccines, Rockville, MD, USA

8. GlaxoSmithKline, Rixensart, Belgium

9. Novartis, East Hanover, NJ, USA

10. AskBio, Research Triangle Park, NC, USA

11. REGENXBIO, Rockville, MD, USA

12. BRI – a Frontage company, Vancouver, BC, Canada

13. Sana Bio, Cambridge, MA, USA

14. BioMarin, Novato, CA, USA

15. Bristol-Myers Squibb, Lawrenceville, NJ, USA

16. Japan MHLW-NIHS, Tokyo, Japan

17. Sangamo, Brisbane, CA, USA

18. Regeneron Pharmaceuticals, Tarrytown, NY, USA

19. Merck, West Point, PA, USA

20. Takeda, Cambridge, MA, USA

21. Novartis, Basel, Switzerland

22. WRIB, Montreal, QC, Canada

23. Health Canada, Ottawa, ON, Canada

24. Norwegian Medicines Agency, Oslo, Norway

25. Takeda, Opfikon, Switzerland

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

27. US FDA, Silver Spring, MD, USA

28. Intellia, Cambridge, MA, USA

29. AbbVie, Irvine, CA, USA

30. AstraZeneca, Gaithersburg, MD, USA

31. Alexion, New Haven, CT, USA

32. Pfizer, Groton, CT, USA

33. UK MHRA, London, UK

34. GlaxoSmithKline, Collegeville, PA, USA

35. Novo Nordisk, Maaloev, Denmark

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

37. Sanofi, Framingham, MA, USA

38. Genentech, South San Francisco, CA, USA

39. Sandoz, Oberhaching, Germany

40. Austria AGES, Vienna, Austria

Abstract

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th 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 biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term “Context of Use – COU”); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 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 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness. Part 1A (Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC), Part 1B (Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine) and Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) are published in volume 14 of Bioanalysis, issues 9 and 10 (2022), respectively.

Publisher

Future Science Ltd

Subject

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

Cited by 11 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3