2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Author:

Spitz Susan1,Zhang Yan2,Fischer Sally3,McGuire Kristina4,Sommer Ulrike5,Amaravadi Lakshmi6,Bandukwala Abbas7,Eck Steven8,Garofolo Fabio9,Islam Rafiqul10,Jordan Gregor11,King Lindsay12,Saito Yoshiro13,Sumner Giane4,Terry Linda14,Vitaliti Alessandra5,Wang Yow-Ming7,Grimaldi Christine15,Joyce Alison16,Palmer Rachel17,Andisik Matthew4,Araya Marcela18,Azadeh Mitra19,Baltrukonis Daniel20,Elliott Rebecca3,Haidar Sam7,Kumar Seema21,Mayer Andrew22,Neff Florian11,Palackal Nisha4,Peng Kun3,Abhari Mohsen Rajabi7,Satterwhite Christina23,Savoie Natasha24,Soo Catherine25,Vinter Stephen26,Welink Jan27,Yan Weili3,Maher Kevin7,Lanham David28,Bertholet Sylvie29,Dakappagari Naveen30,Gonneau Christèle31,Green Cherie3,Junker Fabian32,Kar Sumit24,Patti-Diaz Lisa33,Sarikonda Shyam30,McCausland Megan34,Teixeira Priscila Camillo32,Decman Vilma35,Estevam Jose19,Hedrick Michael36,Robert Alberto Hidalgo3,Hopkins Gregory37,Nuti Sandra29,Tangri Shabnam30,Wnek Richard38,Dandamudi Suman7,Dasgupta Arindam7,Edmison Anna25,Faustino Patrick7,McGuinness Michael26,Lima Santos Gustavo Mendes39,Mirza Tahseen7,Shakleya Diaa7,Stojdl Susan25,Tampal Nilufer7,Zhang Jinhui7,Cherry Elana25,Cludts Isabelle40,Exley Andrew26,Ishii-Watabe Akiko13,Kirshner Susan7,Pedras-Vasconcelos Joao7,Shen Meiyu7,Siggers Richard25,Solstad Therese41,Verthelyi Daniela7,Yan Haoheng7,Zhang Lucia25

Affiliation:

1. Incyte Research Institute, Wilmington, DE, USA

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

3. Genentech, South San Francisco, CA, USA

4. Regeneron Pharmaceuticals, Tarrytown, NY, USA

5. Novartis, Basel, Switzerland

6. Boston Pharmaceuticals, Cambridge, MA, USA

7. US FDA, Silver Spring, MD, USA

8. Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA

9. BRI, Vancouver, BC, Canada

10. Celerion, Lincoln, NE, USA

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

12. Pfizer, Andover, MA, USA

13. Japan MHLW-NIHS, Tokyo, Japan

14. GlaxoSmithKline, Stevenage, UK

15. Boehringer Ingelheim, Ridgefield, CT, USA

16. Pfizer, Groveland, MA, USA

17. Sanofi, Framingham, MA, USA

18. Pfizer, Medford, MA, USA

19. Takeda, Cambridge, MA, USA

20. Pfizer, Groton, CT, USA

21. EMD Serono, Andover, MA, USA

22. GlaxoSmithKline, Collegeville, PA, USA

23. Charles River, Reno, NV, USA

24. CFABS, Montreal, QC, Canada

25. Health Canada, Ottawa, ON, Canada

26. UK MHRA, London, UK

27. EMA, London, UK

28. Eurofins Bioanalysis Services, Abingdon, UK

29. GSK vaccines, Rockville, MD, USA

30. Navigate, a Novartis Subsidiary, San Diego, CA, USA

31. Covance, Meyrin, Switzerland

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

33. Bristol-Myers Squibb, Mt. Laurel, NJ, USA

34. Q2 Solutions, Marietta, GA, USA

35. GlaxoSmithKline, Philadelphia, PA, USA

36. Bristol-Myers Squibb, Holland, PA, USA

37. bluebird bio, Cambridge, MA, USA

38. Merck, Kenilworth, NJ, USA

39. Brazil ANVISA, Brasilia, Brazil

40. UK MHRA-NIBSC, London, UK

41. Norwegian Medicines Agency (NoMA), Oslo, Norway

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 and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS 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 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

Publisher

Future Science Ltd

Subject

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

Reference140 articles.

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