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 <underline>(PART 1A</underline> - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis <underline>PART 1B</underline> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)

被引：5

作者：

Baratta, Mike ^{[1
]}

Jian, Wenying ^{[3
]}

Hengel, Shawna ^{[2
]}

Kaur, Surinder ^{[4
]}

Cunliffe, Jennifer ^{[6
]}

Boer, Jason ^{[5
]}

Hughes, Nicki ^{[7
]}

Kar, Sumit ^{[8
]}

Kellie, John ^{[9
]}

Kim, Yeoun Jin ^{[10
]}

Lassman, Michael ^{[11
]}

Mehl, John ^{[9
]}

Morgan, Ling ^{[12
]}

Palandra, Joe ^{[1
]}

Sarvaiya, Hetal ^{[13
]}

Zeng, Jianing ^{[14
]}

Zheng, Naiyu ^{[14
]}

Wang, Jian ^{[17
]}

Yuan, Long ^{[18
]}

Ji, Allena ^{[15
]}

Kochansky, Christopher ^{[16
]}

Tao, Lin ^{[27
]}

Huang, Yue ^{[20
]}

Maes, Estelle ^{[25
]}

Barbero, Luca ^{[19
]}

Contrepois, Kevin ^{[20
]}

Ferrari, Luca ^{[21
]}

Fu, Yunlin ^{[22
]}

Johnson, Jay ^{[23
]}

Jones, Barry ^{[17
]}

Kansal, Monika ^{[4
]}

Lu, Yang ^{[24
]}

Post, Noah ^{[26
]}

Shen, Honglue ^{[11
]}

Xue, Yongjun ^{[14
]}

Zhang, Yiyue ^{[24
]}

Biswas, Gopa ^{[24
]}

Cho, Seongeun ^{[24
]}

Edmison, Anna ^{[28
]}

Benson, Kimberly ^{[24
]}

Abberley, Lee ^{[9
]}

Azadeh, Mitra ^{[29
]}

Francis, Jennifer ^{[30
]}

Garofolo, Fabio ^{[31
]}

Gupta, Shalini ^{[32
]}

Ivanova, Iordanka ^{[28
]}

Ishii-Watabe, Akiko ^{[33
]}

Karnik, Shane ^{[34
]}

Kassim, Sean ^{[24
]}

Kavetska, Olga ^{[35
]}

机构：

[1] Takeda, Cambridge, MA USA

[2] Seattle Genet, Bothell, WA USA

[3] Johnson & Johnson Innovat Med, Spring House, PA USA

[4] Genentech Inc, South San Francisco, CA USA

[5] Incyte, Wilmington, DE USA

[6] Novartis, Cambridge, MA USA

[7] Biopharma, Toronto, ON, Canada

[8] WRIB, Toronto, ON, Canada

[9] GlaxoSmithKline, Collegeville, PA USA

[10] AstraZeneca, Gaithersburg, MD USA

[11] Merck & Co Inc, Rahway, NJ USA

[12] Mystic Seaport, Mystic, CT USA

[13] Clario, San Mateo, CA USA

[14] Datacolor, Lawrenceville, NJ USA

[15] Chiesi, Boston, MA USA

[16] Exelixis, Alameda, CA USA

[17] CRINETICS Pharmaceut, San Diego, CA USA

[18] Biogen, Cambridge, MA USA

[19] Merck Serono, Ivrea, Italy

[20] AstraZeneca, South San Francisco, CA USA

[21] F Hoffmann La Roche Ltd, Roche Pharm Res & Early Dev pRED, Basel, Switzerland

[22] Novartis, E Hanover, NJ USA

[23] Pfizer, Andover, MA USA

[24] US FDA, Silver Spring, MD USA

[25] AbbVie, Chicago, IL USA

[26] Ionis Pharmaceut, Carlsbad, CA USA

[27] Sanofi, Framingham, MA USA

[28] Hlth Canada, Ottawa, ON, Canada

[29] Ultragenyx Pharmaceut, Cambridge, MA USA

[30] Regeneron, Tarrytown, NY USA

[31] CCTG, Vancouver, BC, Canada

[32] Amgen Inc, Pathol, Thousand Oaks, CA USA

[33] JPMA, Tokyo, Japan

[34] CTU Colorado Springs, Colorado Springs, CO USA

[35] Pfizer, Groton, CT USA

[36] AbbVie, South San Francisco, CA USA

[37] WHO, Geneva, Switzerland

[38] Anvisa, Pharmacovigilance Off, Brasilia, Brazil

[39] Thermo Fisher Sci, Dept Lab Biostat, PPD, Richmond, VA USA

[40] Pfizer, San Diego, CA USA

[41] UK MHRA, London, England

[42] Alturas Analyt, Moscow, ID USA

[43] FAMHP, Brussels, Belgium

[44] Reefy, Randstad, Netherlands

[45] European Med Agcy EMA, EU, Amsterdam, Netherlands

[46] AGES, Vienna, Austria

[47] US FDA, Jefferson, AR USA

[48] Roche Innovat Ctr Munich, Roche Pharm Res & Early Dev, Penzberg, Germany

来源：

BIOANALYSIS | 2024年 / 16卷 / 09期

关键词：

bioanalysis; biomarkers; cell therapy; gene therapy; immunogenicity; vaccine; WRIB; BIOMARKER ASSAY VALIDATION; EMBEDDED TISSUE PROTEOME; PART 2-HYBRID LBA/LCMS; ALDEHYDE OXIDASE; LC-MS/MS; QUANTIFICATION; FOCUS; CALIBRATION; METABOLISM; TECHNOLOGIES;

D O I：

10.1080/17576180.2024.2347153

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The 17(th) Workshop on Recent Issues in Bioanalysis (17(th) WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17(th) WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with this NEW Regulation" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2023 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 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on Mass Spectrometry Assays, Regulated Bioanalysis/BMV (Part 1A) and Regulatory Inputs (Part 1B). Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 7 and 8 (2024), respectively.

引用

页码：307 / 364

页数：58

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