Introduction:
The article discusses the need for a digital transformation in biomanufacturing to improve efficiency and manage complexity. It explores the challenges faced by the biopharmaceutical industry in implementing smart technologies and highlights the potential benefits of adopting new tools and methodologies.
- Biomanufacturing lags behind target identification and drug development in implementing smart technologies.
- The industry is highly regulated and has a paper-based culture, which hinders digital transformation.
- Companies are transitioning to a new process development and manufacturing paradigm, gradually implementing digital tools.
- Janani Swamy, global head of technology transfer programs at Sanofi, emphasizes the importance of organizational engagement and focusing on safety, quality, and right-first-time development practices.
- The VirtECS software developed by Purdue University helps manage manufacturing complexity by creating high-fidelity models of individual facilities.
- Boehringer Ingelheim has developed the AI-assisted Smart Process Design platform to optimize processes and shorten development timelines.
- The transition to digital transformation requires a new mindset and the integration of enabling technologies, such as compliance with FAIR data practices.
Conclusion:
The biomanufacturing industry has the potential to benefit from a digital transformation, but the implementation of smart technologies is still limited. Challenges such as regulation and a paper-based culture need to be addressed. Companies are beginning to transition to a new paradigm, gradually adopting digital tools to improve efficiency and accelerate the development of innovative therapeutics. The integration of technologies, organizational engagement, and a focus on safety and quality are key factors in successfully implementing digital transformation in biomanufacturing.
