2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 - Innovation in Small Molecules and...

Area of Science:

• Bioanalysis
• Pharmaceutical Sciences
• Biotechnology

Background:

• The 13th Workshop on Recent Issues in Bioanalysis (WRIB) convened over 1000 global experts.
• The workshop focused on current challenges in small and large molecule bioanalysis, biomarkers, immunogenicity, and gene therapy.
• Discussions involved techniques such as LC-MS, hybrid LBA/LC-MS, cell-based assays, flow cytometry, and qPCR.

Purpose of the Study:

• To disseminate recommendations and practical solutions from the 2019 WRIB workshop.
• To facilitate advancements in scientific excellence, quality, and regulatory compliance within the bioanalytical community.
• To address key issues in bioanalysis, including innovation in small molecules and method development for large molecules.

Main Methods:

• Consensus-based recommendations derived from extensive workshop discussions.
• Focus on innovative approaches for small molecule and oligonucleotide bioanalysis.
• Exploration of mass spectrometry method development strategies for large molecule bioanalysis.

Main Results:

• This publication (Part 1) presents recommendations on innovation in small molecules and oligonucleotides.
• It also details mass spectrometry method development strategies for large molecule bioanalysis.
• The white paper aims to provide actionable insights for the bioanalytical field.

Conclusions:

• The WRIB workshop serves as a crucial platform for addressing contemporary bioanalytical challenges.
• This white paper provides essential guidance for improving bioanalytical methods and regulatory adherence.
• Continued collaboration and discussion are vital for progress in bioanalysis, biomarkers, immunogenicity, and gene therapy.