Operational Excellence in Process Development in Drug Substance Production

This presentation will highlight Samsung Biologics (SBL) approach to align process development activities with technology transfer and cGMP manufacturing. This alignment allows for rapid technology transfer with robust and compliant manufacturing. In addition, the alignment of process development with regulatory requirements allows SBL to provide a comprehensive regulatory CMC data package including process controls, validation, product comparability and stability. Process development at SBL is embedded within the manufacturing organization and as such colleagues have extensive understanding of at-scale equipment and manufacturing operations across all SBL facilities ranging from 1,000L to 15,000L scale. With 62 licensed products manufactured at SBL, process development colleagues have amassed a broad range of experience and best practice across diverse cell culture and purification processes. The application of standardized process operating procedures enables process development to streamline laboratory scale models and testing to accurately predict at-scale process performance. Technology transfer accelerants include the application of standardized process platforms, manufacturing best practice and small scale laboratory/virtual models. Finally, the development of robust transactional processes for process characterization, technology transfer and process validation enables their efficient application across SBL to fully support cGMP manufacturing corresponding to the product lifecycle phase.