Advanced therapies have transformed treatment for previously untreatable diseases, providing potential cures for genetic disorders. However, the complex manufacturing processes, high costs, and regulatory requirements necessitate an advanced digital strategy, especially during scale-out.
This paper discusses best practices for development of the following key components in cell and gene organizations, highlighting Emerson's role in the process.
The key components are:
- Enhanced process automation and efficiency
- Real-time monitoring and quality control
- Guided workflow
- Flexible electronic batch records
- Data management, integration and traceability
- Predictive analytics and decision support
- Artificial intelligence and large language models
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