AUGUST 2024LIFE SCIENCES REVIEW8IN MY OPINIONBy Nicolas Pivet, VP and GM, Technology Services, CytivaTHE DIGITAL PLANT OF NOW ADVANCING BIOPHARMA MANUFACTURING'S DIGITAL TRANSFORMATION ISN'T A ONE SIZE FITS ALLNicolas Pivethe future is digital. We've heard it, but what, exactly, does it mean for biomanufacturing? How does our industry transition from a heavily manual plant to a digitalized one? The short answer: gradually. The good news is, we've already started. The biopharmaceutical industry has been compelled to advance, in part, by the rapid pace of drug development amid soaring demand for therapeutics, particularly monoclonal antibodies and entirely new classes of biologic drugs. Bioprocessing 4.0 has arrived, but only in pockets. The classification of 4.0 involves the digital transformation of biopharmaceutical manufacturing. It spans the entire product lifecycle, leveraging the Internet of Things (IoT) for connected manufacturing systems, automation, streamlined processes, and real-time data management. However, there remains a pressing challenge to ensure universal recognition of the need for a substantial shift towards digitalizing development and manufacturing processes. Various challenges plague the industry, including the growth, complexity and uncertainty of the drug pipeline. As some move to manufacture smaller batch sizes for personalized medicine, the necessity for increased agility in manufacturing, with the concept of a reconfigurable plant, becomes apparent. Despite our gains, the sector's digital evolution varies based on organizational size, scale, and maturity.Innovative technologies such as data lakes, digital twin technology, virtual and mixed reality (VR and MR) or Advanced Process Control (APC) address these challenges by placing data at the core. Digital twins (accurate simulations of real-world processes) enhance operational efficiency and predictability of batch processes, while smart hardware optimizes overall equipment effectiveness. Despite the potential benefits of digitalization, the biopharma industry lags in digital maturity, hovering at a Level 2 out of 5 on the Digital Plant Maturity Model (DPMM). Resistance to digital practices stems from cybersecurity concerns, general change management, or the cost of implementation. The COVID-19 pandemic prompted a shift towards digital possibilities out of necessity, with companies connecting equipment to networks for remote monitoring. So how do we evolve to a standardized digital industry when adoption varies so greatly? We start by meeting organizations where they are to T
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