Recognizing the importance of this field and the need to provide deeper insights for attendees, ISPE has curated a dedicated a track titled Case Studies in Process Control and Manufacturing Design. Discussion topics include:
- Leveraging AI in Equipment Design: A real-world example of applying various modeling methodologies, including artificial intelligence (AI)/machine learning (ML), will highlight how to effectively guide and optimize the design of complex aseptic filling equipment, and the related efforts to support routine and systematic application. The session will demonstrate how deterministic, model driven design approaches—combining probabilistic modeling and targeted AI—can replace iterative, manual routines with structured digital workflows that improve microbiological risk understanding, validation efficiency, and sterility assurance.
- Bioprocessing Digital Twins Across Process Lifecycle: A dedicated session will deliver a focused examination of hybrid AI models applied to bioprocessing, including the ability for such models to effectively leverage prior knowledge to promote a growing role in process development and validation, and the efficiencies of such applications. The session will further highlight how hybrid modeling enables high fidelity yet interpretable digital twins that support self driving development, trusted manufacturing simulations, and predictive monitoring across the full bioprocess lifecycle.
- AI and Automated Visual Inspection: Two presentations address this key topic, reflecting its continued prominence in the industry. Areas of focus will include insights into the development and validation of these AI-driven automated visual inspection systems from a technical standpoint and the ongoing complexities related to assuring compliance with a regulatory framework that is only recently becoming established. “Vision AI Use Cases in Aseptic Manufacturing” illustrates how vision AI has evolved beyond traditional inspection to actively support aseptic technique compliance and early risk detection—such as glove integrity issues, first-air disruptions, and potential vial breakage—through real-time operator alerts and digital twin–enabled use cases demonstrated in a live manufacturing environment. “AI Automated Visual Inspection: From Algorithm to Audit-Ready” examines what it takes to operationalize these AI-driven AVI systems within a good manufacturing practices context, highlighting the governance, explainability, and lifecycle controls required to transition from algorithm development to an audit-ready, regulator-aligned solution that improves yield while safeguarding product quality and patient safety.
- Addressing Creditability and Trustworthiness: A selection of unique cases from the pharmaceutical industry will be discussed in this session, such as real-time process monitoring and control systems, with a focus on evidence generation to support model credibility and regulatory evaluation. Examples drawing on process analytical technologies, digital twins, and real time monitoring will illustrate how data selection, model validation, and ongoing performance monitoring can be used to systematically evaluate AI credibility and promote regulatory and operational trust.
The included discussions consider both the acute technical and regulatory aspects of model development and deployment for these cases but also address the larger lifecycle considerations that ultimately determine the long-term value proposition and the potential sensitivity to the dynamic and evolving regulatory backdrop. These examples weave in elements that are addressed in the other tracks (e.g., Workforce Preparedness and Organizational Readiness, Case Studies: Implementation, and Validation and GAMP), giving a perspective on how the various considerations coalesce in pharmaceutical manufacturing and how innovators are working through them to deploy the next generation of pharmaceutical manufacturing.
Summit participants will come away equipped with significant insights from the solutions that presenters have developed and have the opportunity to explore these more deeply during question-and-answer (Q&A) sessions and during panel discussions. The Summit will also catalyze broader dialogue that will extend beyond these case study presentations and Q&As, into the networking events and expo halls and serve to support attendees on their path to developing their own unique applications and solutions.
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