2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3– Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

Autor: Lina Loo, Shannon Harris, Mark Milton, null Meena, Wibke Lembke, Flora Berisha, Sylvie Bertholet, Francis Dessy, Robert Dodge, Xiaodong Fang, Michele Fiscella, Fabio Garofolo, Boris Gorovits, Soumi Gupta, Vibha Jawa, Akiko Ishii-Watabe, Brian Long, Yanmei Lu, Timothy Mack, Kristina McGuire, Katrina Nolan, Luying Pan, Bernd Potthoff, Shobha Purushothama, Dean Smith, Therese Solstad, Ivo Sonderegger, Frank Taddeo, Shabnam Tangri, Leslie Wagner, Bonnie Wu, Yuanxin Xu, Susan Kirshner, Daniela Verthelyi, Haoheng Yan, Kimberly Maxfield, Joao Pedras-Vasconcelos, Mohsen Rajabi Abhari, Swati Gupta, Yuling Wu, Manoj Rajadhyaksha, Matthew Andisik, Daniel Baltrukonis, Elana Cherry, Isabelle Cludts, George Gunn, Anders Holm Millner, Gregor Jordan, Sumit Kar, Robert Kubiak, Gregor P Lotz, Rachel Palmer, Kun Peng, Johann Poetzl, Susan Richards, Natasha Savoie, Roland F Staack, Kay Stubenrauch, Meenu Wadhwa, Günter Waxenecker, Tong-Yuan Yang, Lucia Zhang

Publikováno v: Bioanalysis. 14:737-793

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing ph

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3afe57b1fc4098f3f6598721e7bd1b30
https://doi.org/10.4155/bio-2022-0081

Supplementary Methods, Supplementary References, Supplementary Figure 1, Supplementary Tables 1-3 from First-in-Human Phase I Study of Single-agent Vanucizumab, A First-in-Class Bispecific Anti-Angiopoietin-2/Anti-VEGF-A Antibody, in Adult Patients with Advanced Solid Tumors

Autor: Oliver Krieter, Kay Stubenrauch, Kevin Smart, Simona Rossomanno, Tapan Nayak, Anthony Morel, Katharina Lechner, Angelika Lahr, Florian Heil, Izolda Franjkovic, Christophe Boetsch, Andrea Varga, Ratislav Bahleda, Marie Alt, Marie-Paule Sablin, Joan Albanell, Alvaro Taus, Valentina Boni, Elena Garralda, Christophe Massard, Christophe Le Tourneau, Maria Martinez-Garcia, Manuel Hidalgo

Supplementary Table S1. Criteria for defining dose-limiting toxicities; Supplementary Table S2. Plasma pharmacokinetic parameters of vanucizumab on Cycles 1 and 4 following bi-weekly administration of ascending doses of vanucizumab; Supplementary Tab

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::555574349a2403fbb0a8b72519ed80b7
https://doi.org/10.1158/1078-0432.22465118.v1

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

Autor: Swati Gupta, Sylvie Bertholet, Daniela Verthelyi, Jason Delcarpini, George R Gunn, Richard Siggers, Anna Ma, Fabio Garofolo, Lisa Kierstead, Mark Milton, Francis Dessy, Johann Poetzl, Arno Kromminga, Boris Gorovits, Marco Petrillo, Madeleine Dahlbäck, Lynne Jesaitis, Robert J Kubiak, Becky Schweighardt, Mohsen Rajabi Abhari, Kay Stubenrauch, Meina Liang, Yanmei Lu, Susan Kirshner, Haoheng Yan, John Kamerud, Rocio Murphy, Naveen Dakappagari, Holger Koch, Akiko Ishii-Watabe, Yuanxin Xu, Sam Song, Michael A Partridge, Lucia Zhang, Chris Stebbins, Vibha Jawa, Andrew Exley, Elana Cherry, Jim McNally, Manoj Rajadhyaksha, Bart Corsaro, Bonnie Wu, Therese Solstad, Jean-Claude Marshall, Isabelle Cludts, Ivo Sonderegger, Sumit Kar, Tong-Yuan Yang, Roland F Staack, João Pedras-Vasconcelos, Natasha Savoie, Yuling Wu, Samuel O. Pine, Ghanashyam Sarikonda

Publikováno v: Bioanalysis. 13:415-463

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 res

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::78dad76399423931f3bb96a1903bd264
https://doi.org/10.4155/bio-2021-0007

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Autor: Steven Piccoli, Devangi Mehta, Alessandra Vitaliti, John Allinson, Shashi Amur, Steve Eck, Cherie Green, Michael Hedrick, Shirley Hopper, Allena Ji, Alison Joyce, Virginia Litwin, Kevin Maher, Joel Mathews, Kun Peng, Afshin Safavi, Yow-Ming Wang, Yan Zhang, Lakshmi Amaravadi, Nisha Palackal, Sai Thankamony, Chris Beaver, Eris Bame, Thomas Emrich, Christine Grimaldi, Jonathan Haulenbeek, Vellalore Kakkanaiah, David Lanham, Andrew Mayer, Paul C Trampont, Laurent Vermet, Naveen Dakappagari, Catherine Fleener, Fabio Garofolo, Cynthia Rogers, Shabnam Tangri, Yuanxin Xu, Meina Liang, Manoj Rajadhyaksha, Susan Richards, Becky Schweighardt, Shobha Purushothama, Daniel Baltrukonis, Jochen Brumm, Elana Cherry, Jason Delcarpini, Carol Gleason, Susan Kirshner, Robert Kubiak, Luying Pan, Michael Partridge, João Pedras-Vasconcelos, Qiang Qu, Venke Skibeli, Therese Solstad Saunders, Roland F Staack, Kay Stubenrauch, Al Torri, Daniela Verthelyi, Haoheng Yan, Boris Gorovits, Rachel Palmer, Mark Milton, Brian Long, Bart Corsaro, Vahid Farrokhi, Michele Fiscella, Neil Henderson, Vibha Jawa, Jim McNally, Rocio Murphy, Hanspeter Waldner, Tong-Yuan Yang

Publikováno v: Bioanalysis. 11:2207-2244

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::1d81a589202e4c0b3c30c4ddc1d93790
https://doi.org/10.4155/bio-2019-0271

Abstract 570: Developing a novel adaptor CAR-T cell platform based on the recognition of the P329G Fc mutation in therapeutic IgG1 antibodies for adoptive T cell therapy

Autor: Diana Darowski, Mohamed-Reda Benmebarek, Christian Jost, Kay Stubenrauch, Uwe Wessels, Joerg Benz, Anne Freimoser-Grundschober, Ekkehard Moessner, Pablo Umana, Sebastian Kobold, Christian Klein

Publikováno v: Cancer Research. 82:570-570

Chimeric antigen receptor (CAR) T cells have shown promising results for the treatment of blood cancers and various CAR-T cell approaches are in development for use in different tumor indications. Universal or modular CARs do not directly recognize t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::526c1ac04d84dde8b6cf9ddedf98442e
https://doi.org/10.1158/1538-7445.am2022-570