Mai Z, Escobar D, Wang S, Zhang GS | Special Feature | Bioanalysis. 12(23), 1665–1669 (2020)
Keywords: WRIB • bioanalysis • biomarkers • immunogenicity • gene therapy • cell therapy • vaccine
The 14th edition of the workshop on recent issues in bioanalysis (14th WRIB) was held virtually between 15–29 June 2020 with an attendance of over 1000 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. The 14th WRIB included three main workshops, seven specialized workshops that together spanned 11 days to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity and gene and cell therapy. High quality, better compliance to regulations and scientific excellence are always the foundations of this workshop. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated industry/regulators’ consensus on bioanalytical method validation (BMV) of biotherapeutics by mass spectrometry (hybrid assays, LC–MS/MS and HRMS) 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, reviewing, discussing and agreeing upon best approaches aimed to achieve scientific excellence and increase regulatory compliance on bioanalytical issues.