Biopharmaceutical manufacturing generates an enormous amount of data, much of which is still managed through paper-based systems. This limits the ability to search for information, collaborate effectively, ensure compliance, and gain insights into processes. Digitalization aims to address this issue by digitizing data and enabling the use of digital technologies to improve operations.

Digitalization involves bringing data together on a platform and contextualizing it to leverage with various tools for modeling, prediction, and process understanding. This enables the identification of trends and correlations that would be difficult to discover with siloed data.

The implementation of digitalization can lead to significant improvements in productivity, support end-to-end supply chain integration, and accelerate decision-making. The BioPhorum organization envisions this journey as a progression from paper-based facilities to the fully automated and integrated “adaptive plant.”

Digital tools are being developed to enable the convergence of data from multiple systems, providing access to more information more rapidly. These tools make data increasingly connected, actionable, and intelligent, enabling deep process insights, data-driven decision-making, and greater speed and agility.

Software for continuous process verification (CPV) collects and aggregates data throughout a connected biomanufacturing process, allowing for enhanced process understanding, control, and reporting. By applying historical data, a “golden tunnel” can be established, defining the boundaries of a connected process and allowing for real-time monitoring of critical process parameters.

Digital transformation requires more than just advanced technologies. Standardization, accessibility, and upskilling are critical factors for success. Standardization across the industry will facilitate seamless integration of new technologies, while accessibility ensures that data is available to users with different skill levels. Upskilling is necessary to ensure that individuals and organizations can effectively utilize the digital tools and technologies.

In conclusion, digitalization plays a crucial role in optimizing biopharmaceutical manufacturing processes. By digitizing data and leveraging digital tools, companies can improve decision-making, productivity, and integration throughout the supply chain.

Sources:
– Rana Sader and Lee Asplund
– BioPhorum organization

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