2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)

Author:

Yang Eric1,Welink Jan2,Cape Stephanie3,Woolf Eric4,Sydor Jens5,James Christopher6,Goykhman Dina4,Arnold Mark7,Addock Neil8,Bauer Ronald9,Buonarati Michael10,Ciccimaro Eugene11,Dodda Raj5,Evans Christopher1,Garofolo Fabio12,Hughes Nicola13,Islam Rafiq14,Nehls Corey15,Wilson Amanda16,Briscoe Chad17,Bustard Mark18,Coppola Laura19,Croft Stephanie20,Drexler Dieter21,Ferrari Luca22,Fraier Daniela22,Jenkins Rand23,Kadavil John24,King Lloyd25,Li Wenkui26,Lima Santos Gustavo Mendes27,Musuku Adrien28,Ramanathan Ragu29,Saito Yoshiro30,Savoie Natasha31,Summerfield Scott32,Sun Rachel33,Tampal Nilufer24,Vinter Steve34,Wakelin-Smith Jason34,Yue Qin35

Affiliation:

1. GlaxoSmithKline, King of Prussia, PA, USA

2. Dutch MEB, Utrecht, The Netherlands

3. Covance, Madison, WI, USA

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

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

6. Amgen, Thousand Oaks, CA, USA

7. Previously at Bristol-Myers Squibb, Princeton, NJ, USA; currently at Bioanalytical Solution Integration LLC, Burlington, NJ, USA

8. LGC, Cambridge, UK

9. Austria AGES, Wien, Austria

10. Intertek, San Diego, CA, USA

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

12. Angelini Pharma, Pomezia, RM, Italy

13. Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada

14. Celerion, Lincoln, NE, USA

15. PPD, Middleton, WI, USA

16. AstraZeneca, Cambridge, UK

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

18. Health Canada, Ottawa, ON, Canada

19. Apotex, Toronto, ON, Canada

20. WHO, Geneva, Switzerland

21. Bristol-Myers Squibb, Wallingford, CT, USA

22. F. Hoffmann-La Roche, Basel, Switzerland

23. PPD, Richmond, VA, USA

24. US FDA, Silver Spring, MD, USA

25. UCB, Slough, UK

26. Novartis, East Hanover, NJ, USA

27. Brazil Anvisa, Brasilia, Brazil

28. Pharmascience, Montreal, QC, Canada

29. Pfizer, Groton, CT, USA

30. Japan MHLW-NIHS, Tokyo, Japan

31. CFABS, Montreal, QC, Canada

32. GlaxoSmithKline, Ware, UK

33. BASi, West Lafayette, IN, USA

34. UK MHRA, London, UK

35. Novartis, Emeryville, CA, USA

Abstract

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 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 including 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 LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 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. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.

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. 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

2. 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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4. 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);Bioanalysis;2022-06

5. 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on 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);Bioanalysis;2022-05

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