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8 BioPharm International ® Manufacturing and Facilities 2022 eBook www.biopharminternational.com A s pharmaceutical manufacturing grows in pace and complexity, companies are in- creasingly looking to Pharma 4.0 as a solu- tion, with its promise of simplified work- flows, shortened timelines, and more cost-effective routes to market. But while Pharma 4.0 offers many opportunities, the route to achieving Pharma 4.0 is challenging. Prioritizing the wrong technologies ear- ly in the transformation process can have severe and long-lasting impacts, and at every step of the journey pharmaceutical companies are faced with stumbling blocks that can halt progress. The current Pharma 4.0 landscape: little progress, big disconnects Fully realized, Pharma 4.0 is a holistic system connect- ing all aspects of the pharmaceutical value chain: man- ual processes are fully automated; human input is min- imized; and data from inputs, processes, and outputs are easily accessible and seamlessly fed into advanced analytics technologies for continuous improvement. The result is a self-learning system with greater cost and time efficiencies, reduced errors, and better-quality therapeutic products. In pursuit of this, pharmaceutical enterprises are rebalancing their technology portfolios and increas- ing investments in innovative solutions that support Pharma 4.0. However, while this investment and priori- tization is crucial for Pharma 4.0, effectively implement- ing Pharma 4.0 principles continues to challenge the sector. Organizations are therefore taking routes that are often inefficient and short sighted. Some companies, for example, are jumping ahead prematurely, aspiring to lofty goals such as real-time release, or they are looking to implement the most advanced and sophisticated tech- nologies as quickly as possible. Although these goals are important, and the technologies capable of driving some level of improvement, this approach leaves manufactur- ing plants with small, disconnected pockets of automa- tion and advanced capabilities. Smoothing the Path to Pharma 4.0: Challenges and Solutions Nicola Gardner is senior product marketing manager at Thermo Fisher Scientific. By taking a digital maturity-first approach to Pharma 4.0, manufacturers can optimally position themselves for success. KNSSR - STOCK.ADOBE.COM