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
Rok vydání: 2019
Předmět:
Zdroj: Bioanalysis. 11:2207-2244
ISSN: 1757-6199
1757-6180
Popis: 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 research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. 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, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 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 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers New Insights in Biomarker Assay Validation, Current & Effective Strategies for Critical Reagent Management, Flow Cytometry Validation in Drug Discovery & Development & CLSI H62, Interpretation of the 2019 FDA Immunogenicity Guidance and Gene Therapy Bioanalytical Challenges. Part 1 (Innovation in Small Molecules and Oligonucleotides & Mass Spectrometry Method Development Strategies for Large Molecule Bioanalysis) and Part 2 (Recommendations on the 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) are published in volume 11 of Bioanalysis, issues 22 and 23 (2019), respectively.
Databáze: OpenAIRE
Externí odkaz: