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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)

    , , , , ,
    Surinder Kaur†

    Genentech, South San Francisco, CA, USA

    ,
    John Kellie†

    GlaxoSmithKline, Collegeville, PA, USA

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    John Mehl†

    GlaxoSmithKline, Collegeville, PA, USA

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    Anton I. Rosenbaum†

    AstraZeneca, South San Francisco, CA, USA

    ,
    Tim Sikorski†

    GlaxoSmithKline, Collegeville, PA, USA

    ,
    Sekhar Surapaneni†

    Bristol-Myers Squibb, Lawrenceville, NJ, USA

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    Yongjun Xue§

    Bristol-Myers Squibb, Lawrenceville, NJ, USA

    , ,
    Yue Huang§

    AstraZeneca, South San Francisco, CA, USA

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    Kasie Fang§

    GlaxoSmithKline, Collegeville, PA, USA

    ,
    Ellen Casavant§

    Genentech, South San Francisco, CA, USA

    ,
    Linzhi Chen§

    Boehringer Ingelheim, Ridgefield, CT, USA

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    Ola Saad§

    Genentech, South San Francisco, CA, USA

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    Naiyu Zheng§

    Bristol-Myers Squibb, Lawrenceville, NJ, USA

    ,
    Arindam Dasgupta#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Mohsen Rajabi Abhari#¶‡

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Akiko Ishii-Watabe#¶‡

    Japan MHLW, Tokyo, Japan

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Yoshiro Saito#¶

    Japan MHLW, Tokyo, Japan

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Dulcyane Neiva Mendes Fernandes#¶

    Brazil ANVISA, Brasilia, Brazil

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Joseph Bower#

    Precision for Medicine, Chantilly, VA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Chris Burns#¶

    UK MHRA, London, UK

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Kevin Carleton#

    Janssen, Spring House, PA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Seongeun (Julia) Cho#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Xiulian Du#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Marianne Fjording#

    EWG ICH M10, Copenhagen, Denmark

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Fabio Garofolo#

    *Author for correspondence:

    E-mail Address: fabiogarofolo@hotmail.com

    BRI Frontage, Vancouver, BC, Canada

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Sumit Kar#

    WRIB, Montreal, QC, Canada

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Olga Kavetska#

    Pfizer, Groton, CT, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Elham Kossary#¶

    WHO, Geneva, Switzerland

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Yang Lu#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Andrew Mayer#

    GlaxoSmithKline, Collegeville, PA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Nisha Palackal#

    Regeneron, Tarrytown, NY, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Danielle Salha#

    Altasciences, Laval, QC, Canada

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Eric Thomas#

    Labcorp, Indianapolis, IN, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Tom Verhaeghe#

    Janssen, Beerse, Belgium

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Stephen Vinter#¶

    UK MHRA, London, UK

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Katty Wan#

    Pfizer, San Diego, CA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Yow-Ming Wang#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Kathi Williams#

    Genentech, South San Francisco, CA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Eric Woolf#

    Merck, West Point, PA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Li Yang#¶

    US FDA, Silver Spring, MD, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Eric Yang#

    GlaxoSmithKline, Collegeville, PA, USA

    †SECTION 1 – Mass Spectrometry, Chromatography and Sample Preparation (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Abbas Bandukwala¶

    US FDA, Silver Spring, MD, USA

    §SECTION 2 – Mass Spectrometry Novel Technologies, Novel Modalities, and Novel Challenges (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    Shirley Hopper¶‡

    UK MHRA, London, UK

    §SECTION 2 – Mass Spectrometry Novel Technologies, Novel Modalities, and Novel Challenges (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    Kevin Maher¶

    US FDA, Silver Spring, MD, USA

    §SECTION 2 – Mass Spectrometry Novel Technologies, Novel Modalities, and Novel Challenges (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    Joshua Xu¶‡

    US FDA, Jefferson, AR, USA

    §SECTION 2 – Mass Spectrometry Novel Technologies, Novel Modalities, and Novel Challenges (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators and/or major contributors).

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    ,
    Eric Brodsky‡✓

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Isabelle Cludts‡

    UK MHRA, London, UK

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Chad Irwin‡

    Health Canada, Ottawa, ON, Canada

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Julie Joseph‡

    Health Canada, Ottawa, ON, Canada

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Susan Kirshner‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Mohanraj Manangeeswaran‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Kimberly Maxfield‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    ,
    Joao Pedras-Vasconcelos‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Therese Solstad‡

    Norway NoMA, Oslo, Norway

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    ,
    Seth Thacker‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Omar Tounekti‡

    Health Canada, Ottawa, ON, Canada

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Daniela Verthelyi‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    ,
    Meenu Wadhwa‡

    UK MHRA, London, UK

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    ,
    Leslie Wagner‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    ,
    Takenori Yamamoto‡

    Japan MHLW, Tokyo, Japan

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Lucia Zhang‡

    Health Canada, Ottawa, ON, Canada

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    &
    Lin Zhou‡

    US FDA, Silver Spring, MD, USA

    #SECTION 3 – ICH M10 BMV Guideline & Global Harmonization (Authors are presented in alphabetical order of their last name, with the exception of the first 5 authors who were session chairs, working dinner facilitators or major contributors).

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    Published Online:https://doi.org/10.4155/bio-2023-0167

    The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. 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 16th WRIB included 3 Main Workshops and 7 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 the ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th 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 2022 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Mass Spectrometry and ICH M10. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (LBA, Biomarkers/CDx and Cytometry) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 15 and 14 (2023), respectively.

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