AI Article Synopsis

  • The 14th Workshop on Recent Issues in Bioanalysis (14 WRIB) took place virtually from June 15-29, 2020, attracting over 1000 participants from various sectors in the pharmaceutical and biotech industries, as well as regulatory agencies globally.
  • The event featured three main workshops and seven specialized workshops over 11 days, focusing on critical topics such as bioanalysis, biomarkers, immunogenicity, gene therapy, and vaccine development.
  • The associated 2020 White Paper offers recommendations based on discussions from the workshop and is divided into three parts, covering various aspects of bioanalytical practices and regulatory compliance, with some sections published in previous volumes of the journal Bioanalysis.

Article Abstract

The 14 edition of the Workshop on Recent Issues in Bioanalysis (14 WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14 WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the Global 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 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.

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Source
http://dx.doi.org/10.4155/bio-2021-0005DOI Listing

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