2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Author:

Piccoli Steven1,Mehta Devangi2,Vitaliti Alessandra3,Allinson John4,Amur Shashi5,Eck Steve6,Green Cherie7,Hedrick Michael8,Hopper Shirley9,Ji Allena10,Joyce Alison11,Litwin Virginia12,Maher Kevin5,Mathews Joel13,Peng Kun7,Safavi Afshin14,Wang Yow-Ming5,Zhang Yan8,Amaravadi Lakshmi15,Palackal Nisha16,Thankamony Sai8,Beaver Chris17,Bame Eris2,Emrich Thomas18,Grimaldi Christine19,Haulenbeek Jonathan8,Joyce Alison11,Kakkanaiah Vellalore20,Lanham David21,Maher Kevin5,Mayer Andrew1,Trampont Paul C22,Vermet Laurent23,Dakappagari Naveen24,Fleener Catherine25,Garofolo Fabio26,Rogers Cynthia27,Tangri Shabnam24,Xu Yuanxin28,Liang Meina29,Rajadhyaksha Manoj16,Richards Susan10,Schweighardt Becky30,Purushothama Shobha2,Baltrukonis Daniel31,Brumm Jochen7,Cherry Elana32,Delcarpini Jason33,Gleason Carol8,Kirshner Susan5,Kubiak Robert6,Pan Luying34,Partridge Michael16,Pedras-Vasconcelos João5,Qu Qiang35,Skibeli Venke36,Saunders Therese Solstad36,Staack Roland F18,Stubenrauch Kay18,Torri Al16,Verthelyi Daniela5,Yan Haoheng5,Gorovits Boris11,Palmer Rachel10,Milton Mark37,Long Brian30,Corsaro Bart38,Farrokhi Vahid11,Fiscella Michele39,Henderson Neil40,Jawa Vibha41,McNally Jim34,Murphy Rocio42,Waldner Hanspeter43,Yang Tong-Yuan44

Affiliation:

1. GlaxoSmithKline, Collegeville, PA, USA

2. Biogen, Cambridge, MA, USA

3. Novartis Pharma, Basel, Switzerland

4. Immunologix Laboratories, Tampa, FL, USA

5. US FDA, Silver Spring, MD, USA

6. AstraZeneca, Gaithersburg, MD, USA

7. Genentech, South San Francisco, CA, USA

8. Bristol-Myers Squibb, Princeton, NJ, USA

9. UK MHRA-NIBSC, London, UK

10. Sanofi, Framingham, MA, USA

11. Pfizer, Andover, MA, USA

12. Caprion Biosciences, Montreal, QC, Canada

13. Ionis Pharmaceutical, Carlsbad, CA, USA

14. BioAgilytix, Durham, NC, USA

15. Shire/Takeda, Lexington, MA, USA

16. Regeneron Pharmaceuticals, Tarrytown, NY, USA

17. Syneos Health, Princeton, NJ, USA

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

19. Boehringer Ingelheim, Ridgefield, CT, USA

20. PPD, Richmond, VA, USA

21. Eurofins Bioanalysis Services, Abingdon, UK

22. Covance Central Laboratory, Greenfield, IN, USA

23. Sanofi, Montpellier, France

24. Navigate BioPharma Services, Inc., a Novartis subsidiary, San Diego, CA, USA

25. Pfizer, San Diego, CA, USA

26. Angelini Pharma, Pomezia, RM, Italy

27. bluebird bio, Cambridge, MA, USA

28. Alnylam Pharmaceuticals, Cambridge, MA, USA

29. AstraZeneca, South San Francisco, CA, USA

30. BioMarin, Novato, CA, USA

31. Pfizer, Groton, CT, USA

32. Health Canada, Ottawa, ON, Canada

33. Celldex Therapeutics, Needham, MA, USA

34. Shire/Takeda, Cambridge, MA, USA

35. EMD Serono/Merck KGaA, Billerica, MA, USA

36. Norwegian Medicines Agency, Oslo, Norway

37. Novartis, Cambridge, MA, USA

38. GlaxoSmithKline, Rockville, MD, USA

39. REGENXBIO, Rockville, MD, USA

40. AstraZeneca, Molndal, Sweden

41. Merck & Co., Inc., Kenilworth, NJ, USA

42. Merck & Co., Inc., West Point, PA, USA

43. CRISPR Therapeutics, Cambridge, MA, USA

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

Abstract

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 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 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers New Insights in Biomarker Assay Validation, Current & Effective Strategies for Critical Reagent Management, Flow Cytometry Validation in Drug Discovery & Development & CLSI H62, Interpretation of the 2019 FDA Immunogenicity Guidance and Gene Therapy Bioanalytical Challenges. Part 1 (Innovation in Small Molecules and Oligonucleotides & Mass Spectrometry Method Development Strategies for Large Molecule Bioanalysis) and Part 2 (Recommendations on the 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) are published in volume 11 of Bioanalysis, issues 22 and 23 (2019), respectively.

Publisher

Future Science Ltd

Subject

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

Cited by 74 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

1. Long term investigation of formulation buffers to mitigate stability issues of conjugated critical reagents;Journal of Immunological Methods;2024-10

2. LC-MS/MS and EMIT measure the whole blood concentration of cyclosporine A: The two methods yield concordant results within the dynamic range of the latter, but the former shows broader application scenarios;Journal of Chromatography B;2024-06

3. Characterization of anti-drug antibody responses to the T-cell engaging bispecific antibody cibisatamab to understand the impact on exposure;Frontiers in Immunology;2024-05-31

4. 2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2024-05-02

5. 2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies);Bioanalysis;2024-04-17

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