2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

Author:

Welink Jan1,Yang Eric2,Hughes Nicola3,Rago Brian4,Woolf Eric5,Sydor Jens6,Coppola Laura7,Ackermann Brad8,Li Wenkui9,Alley Stephen C10,Arnold Mark11,Berger Isabella12,Briscoe Chad13,Buonarati Michael14,Bustard Mark15,Cancilla Mark5,Cho Seongeun (Julia)16,Duggan Jeff17,Fraier Daniela18,Garofolo Fabio19,Green Rachel20,Haidar Sam16,Hittle Lucinda21,Ishii-Watabe Akiko22,Islam Rafiq23,Jenkins Rand24,Jones Barry25,Kadavil John16,Kassim Sean16,Kavetska Olga4,Blaye Olivier Le26,Lee Anita21,Liu Hanlan27,Mehl John28,Lima Santos Gustavo Mendes29,Musuku Adrien30,Ramanathan Ragu4,Saito Yoshiro22,Savoie Natasha31,Summerfield Scott32,Surapaneni Sekhar33,Szapacs Matthew2,Tampal Nilufer16,Verhaeghe Tom34,Vinter Stephen35,Whale Emma35

Affiliation:

1. EU EMA, London, UK

2. GlaxoSmithKline, King of Prussia, PA, USA

3. Biopharma Services, Toronto, ON, Canada

4. Pfizer, Groton, CT, USA

5. Merck Research Labs, West Point, PA, USA

6. AbbVie Inc., North Chicago, IL, USA

7. Apotex, Toronto, ON, Canada

8. Eli Lilly & Company, Indianapolis, IN, USA

9. Novartis, East Hanover, NJ, USA

10. Seattle Genetics, Bothell, WA, USA

11. Covance, West Trenton, NJ, USA

12. Austria AGES, Wien, Austria

13. PRA Health Sciences, Overland Park, KS, USA

14. Intertek, San Diego, CA, USA

15. Health Canada, Ottawa, ON, Canada

16. US FDA, Silver Spring, MD, USA

17. IXD Bioanalytics, Southbury, CT, USA (previously Boehringer-Ingelheim, Ridgefield, CT, USA)

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

19. Angelini Pharma, Pomezia, RM, Italy

20. LGC, Cambridge, UK

21. Merck & Co., Rahway, NJ, USA

22. Japan MHLW-NIHS, Tokyo, Japan

23. Celerion, Lincoln, NE, USA

24. PPD, Richmond, VA, USA

25. Q2 Solutions, Ithaca, NY, USA

26. France ANSM, Saint Denis, France

27. Catabasis, Cambridge, MA, USA

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

29. Brazil Anvisa, Brasilia, Brazil

30. Pharmascience, Montreal, QC, Canada

31. CFABS, Montreal, QC, Canada

32. GlaxoSmithKline, Ware, UK

33. Celgene, Summit, NJ, USA

34. Janssen Research & Development, Beerse, Belgium

35. UK MHRA, London, UK

Abstract

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. 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 analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies’ Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively.

Publisher

Future Science Ltd

Subject

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

Cited by 37 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. 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

5. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2023-08

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