2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

Author:

Richards Susan1,Amaravadi Lakshmi1,Pillutla Renuka2,Birnboeck Herbert3,Torri Albert4,Cowan Kyra J.5,Papadimitriou Apollon6,Garofolo Fabio7,Satterwhite Christina8,Piccoli Steven2,Wu Bonnie9,Krinos-Fiorotti Corinna10,Allinson John11,Berisha Flora12,Cocea Laurent13,Croft Stephanie14,Fraser Stephanie15,Galliccia Fabrizio16,Gorovits Boris17,Gupta Swati18,Gupta Vinita5,Haidar Sam19,Hottenstein Charles20,Ishii-Watabe Akiko21,Jani Darshana17,Kadavil John19,Kamerud John22,Kramer Daniel23,Litwin Virginia24,Lima Santos Gustavo Mendes25,Nelson Robert26,Ni Yan2,Pedras-Vasconcelos João19,Qiu Yongchang27,Rhyne Paul28,Safavi Afshin10,Saito Yoshiro21,Savoie Natasha29,Scheibner Kara19,Schick Eginhard3,Siguenza Patricia Y.5,Smeraglia John30,Staack Roland F.6,Subramanyam Meena31,Sumner Giane4,Thway Theingi32,Uhlinger David9,Ullmann Martin33,Vitaliti Alessandra34,Welink Jan35,Whiting Chan C.36,Xue Li17,Zeng Rong37

Affiliation:

1. Sanofi, Framingham, MA, USA

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

3. Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland

4. Regeneron Pharmaceuticals, Tarrytown, NY, USA

5. Genentech, South San Francisco, CA, USA

6. Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany

7. Angelini Pharma, Pomezia, RM, Italy

8. Charles River, Reno, NV, USA

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

10. Bioagilytix Labs, Durham, NC, USA

11. LGC, Cambridge, UK

12. Daiichi Sankyo, Edison, NJ, USA

13. Health Canada, Ottawa, ON, Canada

14. WHO, Geneva, Switzerland

15. Pfizer, Groton, CT, USA

16. Italy AIFA, Rome, Italy

17. Pfizer, Andover, MA, USA

18. Allergan, Irvine, CA, USA

19. US FDA, Silver Spring, MD, USA

20. GlaxoSmithKline, Paoli, PA, USA

21. Japan MHLW-NIHS, Tokyo, Japan

22. Eurofins Bioanalytical Services, St Charles, MO, USA

23. Sanofi, Frankfurt am Main, Germany

24. Covance, Indianapolis, IN, USA

25. Brazil Anvisa, Brasilia, Brazil

26. Novimmune, Geneva, Switzerland

27. Shire, Lexington, MA, USA

28. Q2 Solutions, Marietta, GA, USA

29. CFABS, Laval, QC, Canada

30. UCB Biopharma, Braine L’Alleud, Belgium

31. Biogen, Cambridge, MA, USA

32. Amgen, Thousand Oaks, CA, USA

33. EMD Serono, Aubonne, Switzerland

34. Novartis Pharma, Basel, Switzerland

35. Dutch MEB, Utrecht, The Netherlands

36. Aduro Biotech, Berkeley, CA, USA

37. OncoMed Pharmaceuticals, Redwood City, 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 weeklong event – A Full Immersion Week of Bioanalysis for PK, Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on PK, 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 3) discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Parts 1 (small molecule bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

Publisher

Future Science Ltd

Subject

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

Cited by 47 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

3. Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI‐751): Results From a Randomized Phase 1 Trial;Clinical Pharmacology in Drug Development;2023-07-22

4. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach);Bioanalysis;2023-07

5. Fit-for-purpose validation of a drug-tolerant immunogenicity assay for a human mAb drug in animal safety studies;Journal of Immunological Methods;2023-01

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