2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)

作者：Lauren Stevenson, Susan Richards, Renuka Pillutla, Albert Torri, John Kamerud, Devangi Mehta, Stephen Keller, Shobha Purushothama, Boris Gorovits, Virginia Litwin, Christopher Stebbins, Joseph C. Marini, Chris Beaver, Gizette Sperinde, Patricia Siguenza, Roland F. Staack, Yongchang Qiu, Lakshmi Amaravadi, Shashi Amur, Catherine Fleener, Daniel Baltrukonis, Ian M. Catlett, Elana Cherry, Shan Chung, Isabelle Cludts, Lorella Di Donato, Saloumeh K Fischer, Stephanie Fraser, Fabio Garofolo, Cherie Green, George R. Gunn, Sam Haidar, Jonathan Haulenbeek, Neil Henderson, Shirley Hopper, Akiko Ishii‐Watabe, Rafiq Islam, Brian Janelsins, Vibha Jawa, V.N. Kakkanaiah, Szilard Kamondi, Gerry Kolaitis, Robert J Kubiak, Seema Kumar, Pekka Kurki, Meina Liang, Patrick Liu, Kimberly Maxfield, Heather Myler, Nisha Palackal, Rachel Palmer, João Pedras-Vasconcelos, Steven P. Piccoli, Paul Rhyne, Yoshiro Saito, Natasha Savoie, Eginhard Schick, Becky Schweighardt, Judy Shih, An Song, Priya Sriraman, Ludovicus Staelens, Giane Sumner, Yongliang Sun, Martin Ullmann, Daniela Verthelyi, Meenu Wadhwa, Yow‐Ming Wang, Yuanxin Xu, Haoheng Yan, Tong‐Yuan Yang, Rong Zeng · 发表于：Bioanalysis · 年份：2018 · DOI：10.4155/bio-2018-0287 · 被引用次数：54 · 研究领域：Biosimilars and Bioanalytical Methods、CAR-T cell therapy research、Virus-based gene therapy research

The 2018 12th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9–13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion in bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 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 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays. Part 1 (LCMS for small molecules, peptides, oligonucleotides and small molecule biomarkers) and Part 2 (hybrid LBA/LCMS for biotherapeutics and regulatory agencies’ inputs) are published in volume 10 of...