Smart Manufacturing for New Modalities: Rapid, Robust, and Personalized

October 21, 2025 

2:00 PM ET / 1:00 PM CT / 11:00 AM PT / 7:00 PM GMT

Duration: 1 hour 

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Summary

New modalities such as mRNA therapies, cell and gene therapies, and personalized vaccines are fundamentally transforming drug manufacturing and healthcare delivery. Digital solutions are now critical success factors and strategic enablers not only in scaling up production but also in enabling smooth technology transfer from R&D to commercial manufacturing. It has been emphasized for many years to incorporate manufacturability, scalability, and digital integration early in development to streamline operations and reduce costly late-stage adjustments. As batch sizes decrease documentation, compliance, and process control requirements increase substantially, underscoring the need for robust digital infrastructures. 

Today, the manufacturing of new modalities faces significant challenges because, given the inherently small-scale and highly personalized nature of cell therapies, much of the production utilizes equipment originally designed for research or pilot-scale use rather than industrial-scale operations resulting in limited interoperability and fragmented data across disconnected IT systems, which complicates automation and process harmonization. Patient-specific biological variability requires rapid communication, close collaboration, and agile responses from manufacturing teams to effectively adjust processes in real time, ensuring consistent product quality and optimal patient outcomes. Batch release often represents a critical bottleneck, with manual handoffs and extensive documentation prolonging timelines and impacting patient access. The industry’s shift towards patient-centric medicine calls for solutions that harmonize traditional personalized care values with modern digital transparency. Scale-out production models demand standardized human processes supplemented with comprehensive digital oversight to ensure first-time-right manufacturing. Digital platforms that provide a robust backbone for transparency, compliance, and real-time decision-making are essential to enable both rapid-response and personalized therapies to reach patients safely and efficiently. 

Digital transformation in pharma’s new modalities is no longer optional—it is the foundation for realizing the promise of truly personalized, rapidly delivered therapies. This roundtable is your opportunity to connect with industry leaders, challenge assumptions, and co-create the strategic roadmap for digital innovation that will define tomorrow’s healthcare landscape.