%0 Journal Article
%T 2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 ¨C LBA/cell-based assays: immunogenicity, biomarkers and PK assays) | Bioanalysis
%A Akiko Ishii-Watabe
%A Albert Torri
%A An Song
%A Becky Schweighardt
%A Boris Gorovits
%A Brian Janelsins
%A Catherine Aversa Fleener
%A Cherie Green
%A Chris Beaver
%A Christopher Stebbins
%A Daniel Baltrukonis
%A Daniela Verthelyi
%A Devangi Mehta
%A Eginhard Schick
%A Elana Cherry
%A F Staack
%A Fabio Garofolo
%A George Gunn
%A Gerry Kolaitis
%A Giane Sumner
%A Gizette Sperinde
%A Haoheng Yan
%A Heather Myler
%A Ian Catlett
%A Isabelle Cludts
%A John Kamerud
%A Jonathan Haulenbeek
%A Joseph Marini
%A JoŁżo Pedras-Vasconcelos
%A Judy Shih
%A Kimberly Maxfield
%A Lakshmi Amaravadi
%A Lauren Stevenson
%A Lorella Di Donato
%A Ludovicus Staelens
%A Martin Ullmann
%A Meenu Wadhwa
%A Meina Liang
%A Natasha Savoie
%A Neil Henderson
%A Nisha Palackal
%A Patricia Siguenza
%A Patrick Liu
%A Paul Rhyne
%A Pekka Kurki
%A Priya Sriraman
%A Rachel Palmer
%A Rafiq Islam
%A Renuka Pillutla
%A Robert J Kubiak
%A Rol
%A Rong Zeng
%A Saloumeh Fischer
%A Sam Haidar
%A Seema Kumar
%A Shan Chung
%A Shashi Amur
%A Shirley Hopper
%A Shobha Purushothama
%A Stephanie Fraser
%A Stephen Keller
%A Steven Piccoli
%A Susan Richards
%A Szilard Kamondi
%A Tong-yuan Yang
%A Vellalore Kakkanaiah
%A Vibha Jawa
%A Virginia Litwin
%A Yongchang Qiu
%A Yongliang Sun
%A Yoshiro Saito
%A Yow-Ming Wang
%A Yuanxin Xu
%J Bioanalysis
%D 2018
%R https://doi.org/10.4155/bio-2018-0287
%X The 2018 12th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9¨C13, 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 agenciesĄŻ inputs) are published in volume 10 of Bioanalysis, issues 22 and 23 (2018), respectively.
%U https://www.future-science.com/doi/10.4155/bio-2018-0287