Digital business transformation requires business process changes supported by enabling technologies. However, implementing these technologies alone is not the right answer to the challenges that the industry must face. Still, they are a key element of a wider solution, inclusive of revised business and compliance processes, and innovative and sustainable digital solutions.
New opportunities offered by emerging technologies are changing the game and making new scenarios possible, even the ones considered impossible a few years ago. ISPE’s goal is to deep dive into transformations by presenting case studies to achieve benefits from digital solutions. This conference track, “Pharma 4.0™: Case Studies and Lessons Learned,” will highlight practical applications of these technologies in industry case studies, including benefits, challenges, and lessons learned.
Digitalization has opened new avenues for reducing end-to-end (E2E) timelines, enabling faster and more efficient batch release processes. Through data-driven tools and advanced analytics, companies can now produce and release products with greater speed and reliability while maintaining rigorous quality standards. In quality control (QC) operations, artificial intelligence (AI) has shown particular promise—automating complex assessments and enhancing both precision and speed, which ultimately improves the quality and throughput of QC processes.
Further enhancing flexibility and adaptability, modular equipment designs enable seamless integration and standardized data management across processes. This modularity facilitates the use of accurate, real-time data, supporting AI applications that drive continuous process optimization. As a result, pharmaceutical operations can quickly adjust to new requirements or market demands without extensive reconfiguration, ensuring that operations remain resilient and responsive.
These developments underscore a broader industry shift towards streamlined, data-centric operations that not only improve efficiency but also reinforce product quality and safety. By adopting digital solutions that integrate modular and scalable systems, the industry can better harness the potential of AI and other advanced technologies, paving the way for a future that is more adaptable, efficient, and aligned with the high standards of Pharma 4.0.
- “Implementing a Corporate Manufacturing Data Platform” from Takeda Pharmaceuticals will tackle how data collection is a critical topic for each pharmaceutical company and will highlight Takeda’s experience in building a corporate data platform.
- “Global Industrial Data Hub for Pharma 4.0 Manufacturing” – from AVEVA GmbH, Capgemini, and Roche will introduce how a joint approach of Roche, software vendors, and integration partners demonstrated successful data ingestion to a new, cloud-based data platform as a single source of truth.
- “Augment Ops While Building in Quality – a Case Study” from Next Pharma and Tulip Interfaces will share the story of how NextPharma adopted a frontline operations platform as their digital solution for maintaining compliance and quality in their processes. Throughout their digital transformation journey, NextPharma learned that digital solutions should not be focused solely on automation but could also be used to augment their human workforce.
- “Speeding Up and Simplifying Modular Equipment Connectivity” from Merck KGaA, Darmstadt, Germany, and COPA-DATA GmbH will present the overview of Merck KGaA’s digital strategy and the transition from manufacturing to “smart-facturing.” Furthermore, there will be an interesting introduction to modular automation and (module type package (MTP), as applied to process development labs, which have led to a reduction of experiment time by 50 percent as compared with traditional operations in lab settings, along with many other benefits.
- “AI Driven High-Throughput Catalyst Screening” from Bayer will stage benefits and lessons learned from the practical implementation of a Pharma 4.0 approach, which not only covers digital workflow integration but also shows how AI can be practically applied and leads to efficiency gains in day-to-day work.
- “Digitalized Batch Release” from Novo Nordisk will then share the benefits of adopting a common digital solution, as Novo Nordisk did, to support the batch records’ review and release process by displaying batch-related data, required for assessment before batch status assignment, and enabling releasing quality assurances (QAs) to evaluate data, identify any needed actions, and conclude on the final disposition of the batch.
Join us in exploring how Pharma 4.0 is not just transforming processes—but redefining the future of healthcare.
Learn more or register today: ISPE.org/conferences/2024-pharma-40-annex-1-conference.
