2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

Author:

Neubert Hendrik1,Alley Stephen C2,Lee Anita3,Jian Wenying4,Buonarati Michael5,Edmison Anna6,Garofolo Fabio7,Gorovits Boris1,Haidar Sam8,Mylott Bill9,Nouri Parya10,Qian Mark11,Vinter Stephen12,Voelker Troy13,Welink Jan14,Wu Jiang11,Yang Eric15,Yu Hongbin16,Evans Chris15,Summerfield Scott17,Wang Jian18,Bateman Kevin19,Boer Jason20,Dean Brian21,Dillen Lieve22,Faustino Patrick8,Ferrari Luca23,Hughes Nicola24,Luo Lina10,Olah Timothy25,Post Noah26,Spellman Daniel S.19,Sydor Jens15,Zhang Hui1,Zhang Jenny1,Zhang Jinhui8,Fandozzi Christine27,Wilson Amanda28,Fraier Daniela23,Beaver Christopher J.29,Dandamudi Suman8,Dasgupta Arindam8,Elliott Rebecca21,Ji Allena30,Li Wenkui31,McGuinness Michael12,Lima Santos Gustavo Mendes32,Mirza Tahseen8,Savoie Natasha33,Shakleya Diaa8,Sporring Sune34,Stojdl Susan6,Sundman Phillip1,Tampal Nilufer8,Woolf Eric19

Affiliation:

1. Pfizer, Andover, MA, USA

2. Seattle Genetics, Bothell, WA, USA

3. Merck, Kenilworth, NJ, USA

4. Janssen Research & Development, Spring House, PA, USA

5. Intertek, San Diego, CA, USA

6. Health Canada, Ottawa, ON, Canada

7. BRI, Vancouver, BC, Canada

8. US FDA, Silver Spring, MD, USA

9. PPD, Richmond, VA, USA

10. Pfizer, Groton, CT, USA

11. Takeda Pharmaceuticals International Co., Cambridge, MA, USA

12. UK MHRA, London, UK

13. Covance, Salt Lake City, UT, USA

14. EMA, London, UK

15. GlaxoSmithKline, Collegeville, PA, USA

16. Boehringer-Ingelheim, Ridgefield, CT, USA

17. GlaxoSmithKline, Ware, UK

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

19. Merck, West Point, PA, USA

20. Incyte, Wilmington, DE, USA

21. Genentech, South San Francisco, CA, USA

22. Janssen Research & Development, Beerse, Belgium

23. F. Hoffmann-La Roche Ltd, Basel, Switzerland

24. Biopharma Services, Toronto, ON, Canada

25. Bristol-Myers Squibb, Pennington, NJ, USA

26. Ionis Pharmaceuticals, Carlsbad, CA, USA

27. Merck, North Wales, PA, USA

28. AstraZeneca, Cambridge, UK

29. Syneos Health, Princeton, NJ, USA

30. Sanofi, Framingham, MA, USA

31. Novartis, East Hanover, NJ, USA

32. Brazil ANVISA, Brasilia, Brazil

33. CFABS, Montreal, QC, CAN

34. Novo Nordisk, Maaloev, Denmark

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, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) 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 covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

Publisher

Future Science Ltd

Subject

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

Cited by 26 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. 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

2. 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

3. 2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization);Bioanalysis;2024-02-22

4. Hybrid liquid chromatography high resolution and accuracy mass spectrometry approach for quantification of antibody-drug conjugates at the intact protein level in biological samples;European Journal of Pharmaceutical Sciences;2023-09

5. 2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization;Bioanalysis;2023-08

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