2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)

Author:

Hersey Sarah1,Keller Steve2,Mathews Joel3,King Lindsay4,Bandukwala Abbas5,Berisha Flora6,Birchler Mary7,Bower Joe8,Clausen Valerie9,Duarte Jose10,Garofolo Fabio11,Hopper Shirley12,Kar Sumit13,Mabrouk Omar14,Marshall Jean-Claude15,McGuire Kristina16,Naughton Michael17,Saito Yoshiro18,Schuhmann Imelda19,Sperinde Gizette20,Teixeira Priscila10,Vitaliti Alessandra19,Wang Yow-Ming5,Wnek Richard21,Zhang Yan1,Spitz Sue22,Decman Vilma23,Eck Steven24,Estevam Jose25,Goihberg Polina26,Alcaide Enrique Gómez10,Gonneau Christèle27,Hedrick Michael Nathan1,Hopkins Gregory28,Junker Fabian10,Nuti Sandra29,Sommer Ulrike19,Standifer Nathan30,Stevens Chad4,Stevens Erin31,Hendricks Carrie32,Wadhwa Meenu12,Torri Albert16,Ma Mark33,Harris Shannon34,Kumar Seema35,Partridge Michael A16,Caiazzo Teresa4,Chilewski Shannon1,Cludts Isabelle12,Coble Kelly36,Gorovits Boris37,Grimaldi Christine36,Jordan Gregor38,Kamerud John4,Leary Beth4,Liang Meina30,Lim Hanjo20,Mayer Andrew7,O'Connor Ellen24,Palackal Nisha16,Poetzl Johann39,Prior Sandra12,Abhari Mohsen Rajabi5,Savoie Natasha13,Soo Catherine40,Ware Mark6,Wu Bonnie6,Xu Yang41,Yang Tong-Yuan6,Zoghbi Jad32

Affiliation:

1. Bristol-Myers Squibb, Lawrenceville, NJ, USA

2. AbbVie, South San Francisco, CA, USA

3. Ionis, Carlsbad, CA, USA

4. Pfizer, Cambridge, MA, USA

5. US FDA, Silver Spring, MD, USA

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

7. GlaxoSmithKline, Collegeville, PA, USA

8. Precision for Medicine, Bethesda, MD, USA

9. Alnylam, Cambridge, MA, USA

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

11. BRI – a Frontage Company, Vancouver, BC, Canada

12. UK MHRA, London, UK

13. WRIB, Montreal, QC, Canada

14. Biogen, Cambridge, MA, USA

15. Moderna, Cambridge, MA, USA

16. Regeneron, Tarrytown, NY, USA

17. GlaxoSmithKline, Stevenage, UK

18. Japan MHLW-NIHS, Tokyo, Japan

19. Novartis, Basel, Switzerland

20. Genentech, South San Francisco, CA, USA

21. Merck, Kenilworth, NJ, USA

22. Incyte Research Institute, Wilmington, DE, USA

23. GlaxoSmithKline, Philadelphia, PA, USA

24. AstraZeneca, Gaithersburg, MD, USA

25. Takeda, Cambridge, MA, USA

26. Pfizer, Andover, MA, USA

27. Labcorp, Meyrin, Switzerland

28. Bluebird Bio, Cambridge, MA, USA

29. GSK vaccines, Rockville, MD, USA

30. AstraZeneca, South San Francisco, CA, USA

31. Pfizer, Groton, CT, USA

32. Sanofi, Framingham, MA, USA

33. Alexion, New Haven, CT, USA

34. HilleVax, Cambridge, MA, USA

35. EMD Serono, Andover, MA, USA

36. Boehringer Ingelheim, Ridgefield, CT, USA

37. Sana Bio, Cambridge, MA, USA

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

39. Sandoz, Munich, Germany

40. Health Canada, Ottawa, ON, Canada

41. Merck, West Point, PA, USA

Abstract

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included three Main Workshops and seven Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term “context of use” [COU]); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and critical reagent and positive control generation were the special features of the 15th edition. This 2021 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 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry. Part 1A (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) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 9 and 11 (2022), respectively.

Publisher

Future Science Ltd

Subject

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

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