Leveraging analytical and bioprocess platforms for biological product development and commercialization – A meeting report

In May 2025, the International Alliance for Biological Standardization (IABS) held a workshop on analytical and bioprocess platforms for biological product development and commercialization. This workshop explored the use of platform approaches and technologies in product development and registration. The topics discussed included the creation, verification, and maintenance of platform technologies, their lifecycle management, their application in regulatory submissions, and the transition from early clinical trials to commercial approval. The participants highlighted the importance of clearly defining the boundaries and applicability of platform approaches in pharmaceutical development. A consistent and open dialogue between industry stakeholders, regulatory reviewers, and health authorities is essential to ensure a shared understanding and alignment in defining the platform landscape. • Boundaries and applicability of platform approaches in pharmaceutical development must be clearly defined. • Open dialogue between the industry and health authorities ensures a shared alignment in defining the platform landscape. • Continued collaboration and engagement are critical to foster regulatory convergence and mutual learning. • Momentum must be maintained by actively participating in global conversations and by sharing insights. • Industry can support harmonized approaches by discussing with health authorities and publishing their findings.