2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry,...

Area of Science:

• Bioanalysis
• Biomarkers
• Immunogenicity
• Gene Therapy
• Cell Therapy
• Vaccines

Background:

• The 15th Workshop on Recent Issues in Bioanalysis (WRIB) convened nearly 900 professionals virtually.
• Discussions focused on current topics in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy, and vaccines.
• Specialized workshops addressed biomarker assay development and validation (BAV), mass spectrometry, cytometry, and critical reagents.

Purpose of the Study:

• To provide the bioanalytical community with key information and practical solutions.
• To enable advances in scientific excellence, improved quality, and better regulatory compliance.
• To disseminate recommendations from the 15th WRIB discussions.

Main Methods:

• Virtual workshop format accommodating nearly 900 professionals.
• Three Main Workshops and seven Specialized Workshops spanning one week.
• Discussions and recommendations compiled into a comprehensive white paper.

Main Results:

• Part 2 of the white paper covers recommendations on ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, and Accuracy/LLOQ for Flow Cytometry.
• Related content in Part 1A, 1B, and Part 3 covers a broad range of bioanalytical topics.
• The white paper aims to clarify confusion, such as the use of "context of use" (COU) in BAV.

Conclusions:

• The white paper offers practical solutions and key information for the bioanalytical community.
• Recommendations aim to improve scientific rigor, quality, and regulatory adherence.
• This publication (Part 2) is part of a multi-part series from the 2021 WRIB.