ISPE D/A/CH Workshop „Pharma’s Journey to Digital Manufacturing and Supply“
From 15. to 17. of september the workshop “Pharma’s Journey to Digital Manufacturing and Supply”, organized by ISPE D/A/CH, took place at Roche in Basel.
A milestone on the way to Pharma 4.0 - focus on digital networking, AI and practical relevance
Over 130 specialists and managers from pharmaceutical companies, technology providers and authorities – including the EMA, Swissmedic, HPRA and MEB – took part. The aim was to drive forward the digital transformation of pharmaceutical manufacturing and the supply chain.
The innovative format combined keynotes, panels, poster sessions, factory tours and four interactive focal points:
- GenAI in GxP environments
- Predictive Process Modeling
- Digital Twins
- Digital tools for individualized therapies (precision medicines)
A revolutionary workshop format: from stand-alone ideas to collective discussion
Keynotes, panels, poster sessions and factory tours – supplemented by four AI-supported deep dives on GenAI, predictive modeling, digital twins and precision medicines. In so-called World Café sessions, mixed groups discussed predefined questions on risk management, scalability and inspection readiness.A Generative AI summarized answers in real time and made them available to the panels for further discussion.This format proved to be crucial for success: it enabled an open, skills-based dialog between industry and regulators.
4 central topics: The results at a glance
- AI in GxP: The use of GenAI is possible as long as humans bear full responsibility and a validated control strategy is in place.
- Predictive models: The structured life cycle approach and standardized data platforms are basic prerequisites for scalability.
- Digital twins: Real-time data, hybrid architectures (on premise + cloud) and clear data governance are crucial for quality and compliance.
- Individualisierte Therapien: End-to-End-Automatisierung und dezentrale Herstellung erhöhen Agilität, während MES- und Blockchain-Lösungen die „Chain of Identity“ sichern.
Concrete application examples from Sanofi and Roche show: Gen AI accelerates APQR and the processing of deviations. While J&J and Takeda focused on the use of feedback loops and yield optimization. However, the key to success lies not least in data quality, which continues to play a decisive role.
The regulatory panel with representatives from the EMA, Swissmedic, HPRA and industry experts emphasized that the new
- AI is a tool – and must be used for its intended purpose.
- Real problem solving comes before technology.
- Data governance, standardization and human accountability are non-negotiable.
- Early dialog with authorities strengthens trust and promotes digital innovation.
The milestone for Annex 11 & 22
The 2025 workshop was a decisive milestone on the way to digitally mature, networked and patient-centered production systems.The resulting insights and best practices make a valuable contribution to the further development of regulatory frameworks, including the upcoming revisions of EU GMP Annex 11 and 22.
Formats such as this ISPE D/A/CH workshop show how closely research, manufacturing and regulation need to work together to create a smart, efficient and trustworthy pharmaceutical world of the future.
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The full article was published in Pharmaceutical Engineering magazine in the January & February 2026 issue.
