2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and OligonucleotidesMass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)
| Autor: | Christine Fandozzi, Christopher Evans, Amanda Wilson, Dian Su, Melanie Anderson, Valerie Clausen, Lieve Dillen, Fabio Garofolo, Chris Holliman, Elliott Nickbarg, Timothy Olah, Ragu Ramanathan, Hui Zhang, Surinder Kaur, Renuka Pillutla, Hongbin Yu, Kevin Bateman, Lorella Di Donato, Shawna Hengel, Wenying Jian, Barry Jones, John Kellie, Anita Lee, Joe Palandra, Natasha Savoie, Petia Shipkova, Susan Spitz, Matthew Szapacs, Jian Wang, Katherine Wright, Jianing Zeng |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Bioanalysis
Chromatography Oligonucleotide Chemistry 010401 analytical chemistry Clinical Biochemistry Oligonucleotides General Medicine 030226 pharmacology & pharmacy 01 natural sciences Mass spectrometric Small molecule Method development Mass Spectrometry 0104 chemical sciences Analytical Chemistry Small Molecule Libraries 03 medical and health sciences Medical Laboratory Technology 0302 clinical medicine Inventions General Pharmacology Toxicology and Pharmaceutics Chromatography Liquid |
| Zdroj: | Bioanalysis. 11(22) |
| ISSN: | 1757-6199 |
| 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 1) covers the recommendations on Innovation in Small Molecules and Oligonucleotides & Mass Spec Method Development Strategies for Large Molecules Bioanalysis. Part 2 (2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy) and Part 3 (New Insights in Biomarkers Assays 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 The Gene Therapy Bioanalytical Challenges) are published in volume 11 of Bioanalysis, issues 23 and 24 (2019), respectively. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|