2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (<underline>PART 2</underline> - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

被引：0

作者：

Kholmanskikh, Olga ^{[14
]}

Wang, Yow-Ming ^{[7
]}

Hersey, Sarah ^{[2
]}

Wadhwa, Meenu ^{[4
]}

Block, Katherine ^{[1
]}

Bandukwala, Abbas ^{[7
]}

Szapacs, Matthew ^{[3
]}

Weiner, Russell ^{[5
]}

Awwad, Khader ^{[6
]}

Dessy, Francis ^{[8
,9
]}

Downing, Sean ^{[5
]}

Du, Xiulian ^{[7
]}

Garofolo, Fabio ^{[10
]}

Harris, Shannon ^{[11
]}

Hou, Victor ^{[12
]}

Jones, Jennifer ^{[2
]}

Kar, Sumit ^{[13
]}

Kinhikar, Arvind ^{[15
]}

Li, Ming ^{[16
]}

Mathews, Joel ^{[17
]}

Meissen, John ^{[18
]}

Sumner, Giane Oliveira ^{[19
]}

Pan, Luying ^{[5
]}

Sanderink, Gerard ^{[20
]}

Scully, Ingrid ^{[21
]}

Stanta, Johannes ^{[22
]}

Tanaka, Yoichi ^{[23
]}

Vauleon, Stephanie ^{[24
]}

Wagner, Leslie ^{[7
]}

Wang, Kai ^{[25
]}

Zhu, Liang ^{[12
]}

Eck, Steven ^{[27
]}

Lin, Yi-Dong ^{[5
]}

Azadeh, Mitra ^{[26
]}

Decman, Vilma ^{[25
]}

Diebold, Sandra ^{[4
]}

Goihberg, Polina ^{[28
]}

Alcaide, Enrique Gomez ^{[24
]}

Gonneau, Christele ^{[29
]}

Hedrick, Michael Nathan ^{[2
]}

Hopkins, Gregory ^{[30
]}

Loschko, Jakob ^{[21
]}

Mccausland, Megan ^{[31
]}

Mendez, Luis ^{[32
]}

Sehra, Sarita ^{[33
]}

Stevens, Erin ^{[34
]}

Sun, Yongliang Steve ^{[2
]}

Tangri, Shabnam ^{[35
]}

Trampont, Paul C. ^{[12
]}

Cludts, Isabelle ^{[4
]}

机构：

[1] Genentech Inc, San Francisco, CA USA

[2] Bristol Myers Squibb, Lawrenceville, NJ USA

[3] Abbvie, Philadelphia, PA USA

[4] UK MHRA, London, England

[5] Takeda, Cambridge, MA USA

[6] Abbvie, Ludwigshafen, Germany

[7] US FDA, Silver Spring, MD USA

[8] GlaxoSmithKline, Rixensart, Belgium

[9] Takeda, Cambridge, MA USA

[10] BRI Frontage, Vancouver, BC, Canada

[11] HilleVax, Cambridge, MA USA

[12] Moderna, Cambridge, MA USA

[13] WRIB, Toronto, ON, Canada

[14] Belgium FAMHP, Brussels, Belgium

[15] Novartis, Cambridge, MA USA

[16] Stoke, Cambridge, MA USA

[17] Ionis, Carlsbad, CA USA

[18] AstraZeneca, San Francisco, CA USA

[19] Regeneron, Tarrytown, NY USA

[20] Sanofi Pasteur, Swiftwater, PA USA

[21] Pfizer, Pearl River, NY USA

[22] Celerion, Stevenage, England

[23] Japan MHLW, Tokyo, Japan

[24] F Hoffmann La Roche Ltd, Basel, Switzerland

[25] GlaxoSmithKline, Collegeville, PA USA

[26] Ultragenyx, Cambridge, MA USA

[27] AstraZeneca, Gaithersburg, MD USA

[28] Pfizer, Andover, MA USA

[29] Labcorp, Meyrin, Switzerland

[30] 2seventy Bio, Cambridge, MA USA

[31] Q2 Solut, Atlanta, GA USA

[32] Merck, Kenilworth, NJ USA

[33] Incyte, Wilmington, DE USA

[34] Pfizer, Groton, CT USA

[35] Navigate, San Diego, CA USA

[36] Alexion, New Haven, CT USA

[37] Spark Therapeut, Plainsboro, NJ USA

[38] Pfizer, Kirkland, PQ, Canada

[39] Fresenius Kabi, Bad Homburg, Germany

[40] Sanofi, Ghent, Belgium

[41] Frontage, Exton, PA USA

[42] Alnylam, Cambridge, MA USA

来源：

BIOANALYSIS | 2024年 / 16卷 / 08期

关键词：

bioanalysis; biomarkers; cell therapy; gene therapy; immunogenicity; vaccine; WRIB; PART 2-HYBRID LBA/LCMS; EXTRACELLULAR VESICLES; REGULATED BIOANALYSIS; SMALL MOLECULES; FOCUS; IMMUNOGENICITY; CALIBRATION; INPUT; 3-LBA; GENE;

D O I：

10.1080/17576180.2024.2340961

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on 19-23 June 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 17th 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 these NEW Regulations" 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 (Part 2) covers the recommendations on Biomarkers, IVD/CDx, LBA and Cell-Based Assays. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 9 and 7 (2024), respectively.

引用

页码：179 / 220

页数：42

共 1 条

[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
Sumner, Giane
Keller, Steve
Huleatt, James
Staack, Roland F.
Wagner, Leslie
Azadeh, Mitra
Bandukwala, Abbas
Cao, Liching
Du, Xiulian
Salinas, Gabriela Franco
Garofolo, Fabio
Harris, Shannon
Hopper, Shirley
Irwin, Chad
Ji, Qin
Joseph, Julie
King, Lindsay
Kinhikar, Arvind
Lu, Yang
Luo, Rosa
Mabrouk, Omar
Malvaux, Ludovic
Marshall, Jean-Claude
McGuire, Kristina
Mikol, Vincent
Neely, Robert
Qiu, Xiazi
Saito, Yoshiro
Salaun, Bruno
Scully, Ingrid
Smeraglia, John
Solstad, Therese
Stoop, Jeroen
Tang, Huaping
Teixeira, Priscila
Wang, Yixin
Wright, Mike
Mendez, Luis
Beaver, Chris
Eacret, Jacqueline
Au-Yeung, Amelia
Decman, Vilma
Dessy, Francis
Eck, Steven
Goihberg, Polina
Alcaide, Enrique Gomez
Gonneau, Christele
Grugan, Katharine
Hedrick, Michael Nathan
Kar, Sumit
[J]. BIOANALYSIS, 2023, 15 (15) : 861 - 903

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