At the 2022 ISPE Europe Annual Conference, taking place in Madrid this week, we are hearing innovative and insightful talks about industry-critical topics with a focus on sustainability, digital quality and trends in pharmaceutical engineering.  

The frontiers of machine learning (ML) are shaping new dimensions as a key enabler of pharmaceutical quality surveillance (PQS). Nandini Rakala, Visiting Associate from the U.S. FDA, showed how ML can be used to not only predict the pharma quality system but also to establish an assessment framework covering both quantitative and qualitative (quality policy, resource management, internal communication) metrics, yielding a surveillance tool that can be used to obtain objective measures of manufacturing quality, enabling sustainable cGMP (current Good Manufacturing Practice) compliance.  

As we think about the digitalization journey pharma companies are undertaking and their different stages, it becomes clear how artificial intelligence (AI) plays a pivotal role in solving business challenges. We’ve heard about the benefits of AI in development and manufacturing to tackle assumptions, weak statistics and invasive sampling yet, in some cases, it remains a “black box” that proves insufficient to be validated in GMP environments. An innovative approach to this issue has been presented by Fresenius Kabi Austria GmbH. Their AI-supported detection system performed in the aseptic core of an isolator can detect and classify interventions by using an “XAI” system extension, which aims to explain to the user how AI arrived at certain decisions and what limitations there are.  

Another prevalent theme at this week’s meeting has been how biology and digital come together to accelerate current value chains, with an example being cell and gene therapy (CGT). CGT is envisioned as the third pillar of medicine in this decade, along with mRNA. Bayer AG is an example of a company that frontlines innovation in CGT tech platforms, which are able to address multiple therapeutic areas, for example, allowing for restoration of biological functionality and treating intractable diseases. Wolfram Carius, Executive VP at Bayer AG, explained how the life sciences industry is at the start of a paradigm shift – small molecules + biologics + advanced therapies –moving towards their holistic integration enabled by control, scaling and digitalization.  

We ended the day learning more about the Sustainable Drug Discovery and Development with End-of-Life Yield (SUDDEN) project. This brilliant, multidisciplinary project aims to develop new solutions to tackle the environmental impacts of medicines from a lifecycle perspective; starting from drug discovery, through production, distribution and all the way to consumption and disposal. Thus, to embrace sustainability as whole in the pharmaceutical sector, the integration of economic, environmental and social dimensions must be considered. Consequently, experts in drug discovery, economics, international environmental law, water purification technology, and plastic recycling intensively collaborate and interact to propose solutions both at a molecular and product level. For instance, within drug discovery, the SUDDEN team has developed computational tools to predict biodegradability, as well as in vitro effect models for assessment of bioaccumulation in fish. 

Thank you to ISPE for a dynamic day during the European Annual Meeting. Great to be back face-to-face! 

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