Wednesday 19th March - Main Conference Day OneWednesday, 19 March 2025 - PT (Pacific Time, GMT-08:00)

• Insights and best practices for successful implementation
• Achieving scalable optimization
• Ensuring user adoption

As biopharmaceuticals grow in complexity and demand, the shift from traditional batch processing to integrated continuous manufacturing (ICB) has emerged as a compelling solution to reduce cost, waste and time to launch. However, integrating continuous manufacturing in bioprocessing requires a realistic evaluation of both opportunities and challenges. Key topics include the availability of commercially ready plug-and-play modular technologies, integration of real-time monitoring and development of robust control strategies. By examining the status of ICB implementation and recent innovations, we’ll outline a roadmap for adopting continuous bioprocessing practices and suggest actionable steps for industry stakeholders. The goal of this presentation is to provide a practical perspective on what is realistically achievable in the near term and to encourage a collaborative approach to realizing the potential of continuous manufacturing in bioprocessing.

High-performance liquid chromatography (LC) and mass spectrometry (MS) are proven tools for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, LC-MS has been performed off-line – a process that can take days or weeks to complete. By moving LC-MS to the manufacturing floor as an on-line Process Analytical Technology (PAT) tool, relevant data can be accessed in a matter of minutes. In this presentation, we highlight an initial use case, demonstrating the utility of LC-MS to monitor and control antibody CQAs in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.