ELCA supports Tigen to accelerate cell-based cancer therapies

Cell and Gene Therapies (CGT) offer unprecedented opportunities for potentially curing diseases where there are currently limited or no treatment options. While showing high efficacy in early clinical trials, the novel therapies also come with new operational challenges, from close collaboration between multiple inter-disciplinary teams to the manufacturing and quality control of the product.


Precision medicine, and especially Cell and Gene Therapies (CGT), require the very close collaboration of many functional experts based on complex processes that need automation and synchronization. At the start of our joint initiative, many interactions between the parties were based on Microsoft Excel tables that were exchanged via email, preventing a fast and safe collaboration. Just one obvious example of how the joint digital solution helped automate, reduce risks, and prevent failures. 


As part of the fully digital Tigen manufacturing solution, Tigen aimed to also digitalize these processes. The goals of the project were:
 

• A collaborative platform where all stakeholders—clinical teams, manufacturing, and compliance—can easily access up-to-date and reliable information, built on privacy by design
• Create digital twins of production sites to monitor processes in different locations
• Automation of process data collection reduces failure rates and enables more reliable quality control
• Central data capture from the processes located in different hospitals.

The digital twins are foundational for the implementation of data science and are a critical element for the scalability of the manufacturing solution. They allow for:
 

• Ensuring quality and compliance for each stakeholder and throughout each process
• Storing clinical and manufacturing data with best-in-class data protection and security policies
• Continuously improving manufacturing processes through data science
• A solution that is scalable by design. Able to be rapidly and efficiently deployed to other hospitals while maintaining the highest security standards.
   

Thanks to its ability to adapt or create new applications in a short time, Tigen Pharm's agility has substantially increased, which allows them to provide more valuable services to partner hospitals faster.