Beyond Basics: New Insights into Bioanalysis from the 2024 Workshop

In May 2024, San Antonio, Texas, played host to the 18th Workshop on Recent Issues in Bioanalysis (18th WRIB). This annual gathering brings together over 1, 100 experts from pharmaceutical and biotech companies, contract research organizations (CROs), and regulatory agencies. The week-long event is dedicated to discussing the latest challenges and solutions in bioanalysis. The workshop was divided into three main sessions and seven specialized workshops, covering a broad range of topics. This included immunogenicity, gene therapy, cell therapy, vaccines, and biomarkers. Two standout sessions focused on the implementation of the In Vitro Diagnostic Regulation (IVDR) in the European Union and the changes in laboratory-developed tests (LDTs) in the United States. Additionally, there were discussions on harmonizing vaccine clinical assay validation.The 2024 White Paper, released following the workshop, offers practical recommendations and insights gathered from these expert discussions. The aim is to enhance scientific excellence, improve quality, and increase regulatory compliance in the bioanalytical community. The paper is split into three parts, with Part 3 specifically addressing advanced strategies for molecular assays and immunogenicity in gene, cell, and vaccine therapies, as well as biotherapeutics. The paper provides crucial guidance on emerging technologies and methods for immunogenicity assessment. It also dives into the regulatory inputs from agencies concerning these therapies. This helps ensure that the bioanalytical community stays up-to-date and well-prepared for the future of biotherapeutics.