Skip to Main Content

7,538

Views

0

CrossRef citations to date

0

Altmetric

White Paper

2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)

Luying Pan1 Takeda, Cambridge, MA, USA

,

Johanna Mora13 Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Karl Walravens3 GlaxoSmithKline, Rixensart, Belgium

,

Leslie Wagner19 US FDA, Silver Spring, MD, USA

,

Shirley Hopper9 UK MHRA, London, UK

,

Lina Loo2 Vertex, Boston, MA, USA

,

David Bettoun4 Larimar, Bala-Cynwyd, PA, USA

,

Sarah Bond5 Alnylam, Cambridge, MA, USA

,

Francis Dessy3 GlaxoSmithKline, Rixensart, Belgium

,

Sean Downing1 Takeda, Cambridge, MA, USA

,

Fabio Garofolo6 BRI Frontage, Vancouver, BC, CanadaCorrespondence[email protected]

,

Soumi Gupta7 BioMarin, Novato, CA, USA

,

Neil Henderson8 AstraZeneca, Gothenburg, Sweden

,

Chad Irwin10 Health Canada, Ottawa, ON, Canada

,

Akiko Ishii-Watabe11 Japan MHLW, Tokyo, Japan

,

Sumit Kar12 WRIB, Montreal, QC, Canada

,

Vibha Jawa13 Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Julie Joseph10 Health Canada, Ottawa, ON, Canada

,

Ludovic Malvaux3 GlaxoSmithKline, Rixensart, Belgium

,

Jean-Claude Marshall14 Moderna, Mystic, CT, USA

,

Jessica McDevitt13 Bristol Myers Squibb, Lawrenceville, NJ, USA

,

Susovan Mohapatra15 Stoke, Cambridge, MA, USA

,

Jessica Seitzer16 Intellia, Cambridge, MA, USA

,

Justin Smith17 Pfizer, Groton, CT, USA

,

Therese Solstad18 Norway NoMA, Oslo, Norway

,

Hiroshi Sugimoto1 Takeda, Cambridge, MA, USA

,

Omar Tounekti10 Health Canada, Ottawa, ON, Canada

,

Bonnie Wu20 Janssen R&D, Spring House, PA, USA

,

Yuling Wu21 AstraZeneca, Gaithersburg, MD, USA

,

Yuanxin Xu16 Intellia, Cambridge, MA, USA

,

Joshua Xu22 US FDA, Jefferson, AR, USA

,

Takenori Yamamoto11 Japan MHLW, Tokyo, Japan

,

Lin Yang23 REGENXBIO, Rockville, MD, USA

,

Albert Torri24 Regeneron, Tarrytown, NY, USA

,

Susan Kirshner19 US FDA, Silver Spring, MD, USA

,

Kimberly Maxfield19 US FDA, Silver Spring, MD, USA

,

Joao Pedras Vasconcelos19 US FDA, Silver Spring, MD, USA

,

Mohsen Rajabi Abhari19 US FDA, Silver Spring, MD, USA

,

Daniela Verthelyi19 US FDA, Silver Spring, MD, USA

,

Eric Brodsky19 US FDA, Silver Spring, MD, USA

,

Montserrat Carrasco-Triguero25 Sangamo, Brisbane, CA, USA

,

John Kamerud17 Pfizer, Groton, CT, USA

,

Matthew Andisik24 Regeneron, Tarrytown, NY, USA

,

Daniel Baltrukonis17 Pfizer, Groton, CT, USA

,

Nicoletta Bivi26 Lilly, Indianapolis, IN, USA

,

Isabelle Cludts9 UK MHRA, London, UK

,

Kelly Coble27 Boehringer Ingelheim, Danbury, CT, USA

,

Boris Gorovits28 Sana Bio, Cambridge, MA, USA

,

George R Gunn29 GSK, Collegeville, PA, USA

,

Swati Gupta30 AbbVie, Irvine, CA, USA

,

Anders Holm Millner31 Novo Nordisk, Maaloev, Denmark

,

Alison Joyce17 Pfizer, Groton, CT, USA

,

Robert J Kubiak21 AstraZeneca, Gaithersburg, MD, USA

,

Seema Kumar32 EMD Serono, Boston, MA, USA

,

Karen Liao33 Merck, West Point, PA, USA

,

Mohanraj Manangeeswaran19 US FDA, Silver Spring, MD, USA

,

Michael Partridge24 Regeneron, Tarrytown, NY, USA

,

Samuel Pine34 Sanofi, Ghent, Belgium

,

Johann Poetzl35 Sandoz, Oberhaching, Germany

,

Manoj Rajadhyaksha36 Alexion, New Haven, CT, USA

,

Michele Rasamoelisolo37 Teva, West Chester, PA, USA

,

Susan Richards38 Sanofi, Framingham, MA, USA

,

Yuan Song39 Genentech, South San Francisco, CA, USA

,

Steven Swanson39 Genentech, South San Francisco, CA, USA

,

Seth Thacker19 US FDA, Silver Spring, MD, USA

,

Meenu Wadhwa9 UK MHRA, London, UK

,

Andreas Wolf40 Amgen, Munich, Germany

,

Lucia Zhang10 Health Canada, Ottawa, ON, Canada

&

Lin Zhou19 US FDA, Silver Spring, MD, USA

Citations (0)

Keep up to date with the latest research on this topic with citation updates for this article.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.