Abstract
Software-Defined Automation for Manufacturing Agility in Regulated Environments
The pharmaceutical manufacturing sector is entering a structural transition driven by a convergence of business, regulatory, and technological pressures.
Shorter time-to-market requirements, small-batch and high-mix production economics driven by the rise of personalized therapies, distributed manufacturing across regional supply networks with inter-facility data interoperability, and the regulatory trajectory toward real-time release testing are some of the factors which are collectively redefining what a next-generation automatic machine must be capable of — and what its underlying control and information architecture must support.
This presentation argues that software-defined automation, combined with executable digital twin architectures, provides the technical foundation for meeting these requirements in a regulatory-compliant manner. Drawing on the Bologna Pilot Project — a consortium initiative developing a full pharmaceutical packaging line built on software-defined automation in Bologna — the paper examines how the transition from hardware-defined to software-defined control opens a viable pathway toward Plug & Produce interoperability and Module Type Package standardisation, reducing integration overhead, revalidation burden, and supplier lock-in across the equipment lifecycle.
The pilot also positions the Asset Administration Shell, developed within the Industrial Digital Twin Association framework, as a candidate architecture for the information layer that regulated manufacturing environments require but OEM offerings have not yet addressed — a hypothesis the Bologna demonstrator is designed to test.
The presentation is delivered in the capacity of Regional Branch Organiser of the Digital Twin Consortium, whose Pharma and Regulatory sub-Working Group is actively developing the digital twin taxonomy for regulated manufacturing environments.
Giuseppe Padula
Research Associate, University of Bologna | Regional Branch Organiser, Digital Twin Consortium
Biography
Giuseppe Padula is an independent consultant specializing in software-defined manufacturing and digital twin architectures, with focus on regulated industrial environments. He serves as Regional Branch Organiser for the Digital Twin Consortium and is a Research Associate at the University of Bologna. He conceived and leads the Bologna Pilot Project, a multi-stakeholder consortium initiative designing a distributed computing and distributed AI ecosystem for pharmaceutical manufacturing, in which software-defined automation and executable digital twins function as foundational architectural components. The project is developed in partnership with SEW-Eurodrive Italy and world-leading OEMs in pharmaceutical downstream processing. He is an active participant in the Industrial Digital Twin Association (IDTA) and collaborates with ISPE on Module Type Package definition for modular pharmaceutical manufacturing. His work operates at the intersection of advanced automation architectures, asset information standards, and the emerging regulatory frameworks that govern their adoption — including FDA Computer Software Assurance guidance, the anticipated revision of EU GMP Annex 11, and the ISPE Good Practice Guide on Module Type Package. His consulting practice bridges OEM equipment design, end-user digital transformation, and the regulatory pathways that make advanced digital architectures viable in quality-critical manufacturing.
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