From cutting-edge technologies to practical strategies that improve everyday performance, this track offers a grounded, well-rounded look at how manufacturers are balancing forward momentum with dependable quality. Here’s a look at what’s in store.
Reimagining Manufacturing Through Innovation
Biologics manufacturing is undergoing a major shift thanks to transformative technologies like continuous bioprocessing, real-time analytics, and artificial intelligence (AI). Speakers from Genentech, NNE, and Novo Nordisk will showcase their innovative fleet management strategy, a novel approach to distributed manufacturing that brings consistency and agility across global sites. Attendees will also hear an industry-wide update on the advancement of transportable and point-of-care (POC) manufacturing platforms, as the field moves toward flexible, scalable solutions that meet demand without compromising compliance or cost-effectiveness.
From Data to Deployment: Making Automation and AI Work
Automation, AI, and digitalization are more than buzzwords—they're essential tools for driving operational efficiency in GMP settings. Attendees will hear practical lessons from real-world AI applications, including strategies for aligning teams, identifying the right use cases, and building trust in algorithm-driven decisions. A featured case study will demonstrate how manufacturers can extract actionable insights from messy or incomplete data. The track also includes a deep dive into Eli Lilly and Company’s paperless Research Triangle Park facility, where fully integrated automation has accelerated ramp-up timelines, increased reliability, and boosted overall performance.
Leading Through Change: Organizational Models That Work
Operational excellence relies on people just as much as technology. Sanofi will walk through their transformation of a global engineering organization, illustrating how tech-enabled structures and mobility can elevate both performance and talent development. One session will explore a Strategic Outsourcing and Relationships (SOAR) framework that simplifies processes and strengthens alignment across teams, partners, and providers, driving greater efficiency in complex environments. Another presentation offers practical strategies for sustaining momentum through mergers, acquisitions, and digital transformation, helping leaders manage change without overextending their teams.
Smarter Validation for Sterile Manufacturing
Sterile manufacturing is evolving, with new approaches that streamline operations without compromising safety. Presentations in this session explore low-concentration vapor phase hydrogen peroxide (VPHP) as a solution to reduce downtime without sacrificing safety and share a case study on overcoming cleaning validation challenges during design transfer. There’s also a forward-looking discussion on integrating automated hydrogen peroxide decontamination into both new and legacy restricted access barrier systems (RABS), offering scalable options for enhanced sterility assurance.
Scaling Up and Looking Ahead
Future-ready facilities need to be designed with adaptability in mind. Integrated Dynamic Bioprocessing (IDB) is gaining traction as a breakthrough model for continuous upstream operations, even at significant production scales. Attendees will also gain insights from the buildout of a next-gen oligonucleotide facility designed to meet today’s needs while leaving room to scale, evolve, and innovate long-term.
Conclusion
This track doesn’t just highlight where pharmaceutical manufacturing is headed, it’s about how we get there together. Attendees will hear from people who are solving real-world problems with creative, effective strategies; from optimizing sterile operations to scaling facilities for the future. The insights shared here are designed to help professionals make meaningful progress, from navigating regulatory complexity to leading a digital transformation to simply trying to improve performance on the plant floor. Join ISPE in Charlotte, North Carolina, to connect with peers, learn from industry leaders, and be part of the conversations shaping the future of pharmaceutical manufacturing. Let’s build what’s next together!
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