Investigating Innovation at ISPE: 2025 Europe Annual Conference

The 2025 ISPE Europe Annual Conference was held May 12-14, 2025 in London, UK, bringing together a community of pharmaceutical engineers and professionals from all industry levels to discover the latest in pharmaceutical technologies and innovations. 

This year’s Europe Annual Conference, hosted at the Novotel London West, feature speakers from the MHRA, the EMA, the EFPIA, GSK, AstraZeneca, and more, covering conference tracks including Biotech – Large Molecules, Cell & Gene, and ATMPs, Pharma 4.0 and Digital Transformation, Good Engineering Practice, and Sustainability. 

Keep reading below for conference session highlights, straight from the tracks themselves. 

Navigating the Digital Transformation Journey 

Luis Miranda, Director, GRA Digitalization Lead at CSL Behring AG, led a holistic overview on incorporating technology to digitally transform business outcomes. “In this regard, Pharma is lagging – we are an industry often perceived as slower adopters of change because of regulatory constraints,” Miranda stated. “We need regulations because we need patient and product safety, but we have proven that we are not only able to do proper research for innovative medicines, but also to manufacture them in more efficient and innovative ways. The nature of ecosystem is evolving – regulations and innovations are not only necessary but they must co-exist.”  

This shift in mindset was at the forefront of Miranda’s case study – rather than focusing on implementing digital transformations at will, establishing a strategic framework to understand what technologies are needed to accomplish the business outcomes can then be used to develop a digitalisation strategy. “Digital transformation is the integration of technology into all aspects of a business,” concluded Miranda. “Regulation and innovation can co-exist in the pharma industry, and staying focused on objectives while being flexible is key for gradual and constant improvement.” 

The Potential of Automation in Cell and Gene Therapies 

With cell and gene therapies (CGTs) transforming the way we treat previously ‘incurable’ diseases, pharmaceutical manufacturers are contending with scaling operations to meet the demand for these medicines. 2500 CGTs are currently in clinical trials and the market is set to exceed US$70 billion by 2030, as referenced by Dr Dan Strange of Cellular Origins, Marco Flori of Staubli, and Kevin Vela of Cell and Gene Therapy Catapult. 

However, CGTs are incredibly space-intensive and require a highly skilled labour force for production. Because of this, automating the production pipeline with mobile robotics to link the GMP units could help create scaleable modular factories with advanced robotics and integrated mobile robotics with cleanroom compatibility. Such technologies can enable both the automation and the integration of existing GMP unit operations. The result is a reliable, flexible, and recoverable facility and workflow. 

Policy for the Future & Globalized Industry: UK Perspective 

Other sessions at ISPE were decidedly more policy focused, such as Expert GMP Inspector of the MHRA’s Ian Jackson’s session ‘Policy for the Future & Globalized Industry: UK Perspective.” As the UK regulatory of medicines, medical devices, and all related healthcare and medicinal products, the MHRA are responsible for establishing set standards and guidance for safety, quality, and efficacy. Jackson’s session introduced the MHRA’s current stance and decisions on such trending topics as AI regulation for use in medical product manufacturing and operations, enabling clinical research innovation, and enabling manufacturing innovation, among others. 

Initiatives like the AI Airlock Sandbox, which provides a safe space to test current medical device regulatory pathways with innovative AI medical device products, and new regulations coming into effect in the next year on effective approval processes and research transparency were just some of the highlighted steps the MHRA are taking to meet the pharmaceutical industry where it is in terms of innovation.