The Eurofins BioPharma Product Testing (EBPT) Global Technical Councils are comprised of Eurofins subject matter experts (SMEs) from sites across the US, EU and Asia. In 2022, the main active councils and sub councils/working groups held approximately 70 meetings, covering challenges affecting: Biologics (Biochromatography, Potency, Electrophoresis), Cell & Gene Therapy (ddPCR, Chromatography, Replication Competent Assays, Residual Impurities), Compendial, Microbiology, Qualified Persons (EU Only), Dissolution, Metrology, New Buildings, Medical Services (Consultancy, Chemical Characterisation).
These effective and valuable forums assemble SMEs to collaborate, harmonise, strategise and troubleshoot. The goal is building inter-laboratory relationships to share knowledge and experience across our extensive laboratory network. Councils have developed harmonised approaches and guidelines with regards to regulatory requirements (Annex 1 tool for gap analysis) and method transfers, and have drafted white papers, webinars and training materials. Another positive outcome is the ability to develop a strategy for investments and new method and service implementation as a result of identifying trends in the industry and new technologies at a global level.
Ultimately, these technical councils allow us to better serve our clients. Any site can bring forward an analytical or regulatory issue to the broader group, as an ideal troubleshooting platform. There is a high probability that another site has already faced a similar issue and can offer a quick resolution. For example, since the pandemic, an increased frequency of supply chain and quality issues have been observed with critical laboratory consumables (standards, kits, reagents and columns). In most situations, one EBPT laboratory has already encountered the same situation and can save the other EBPT laboratories valuable time by sharing root causes and offering suggestions and alternatives. This allows us to sustain support of our clients’ supply chain and provide their valuable products to the patients that need them. For more information, contact your Project Manager.