CPI helps demonstrate autonomous bioreactor control for a HER2 breast cancer therapeutic through a Canada-UK collaboration

CPI is one of three companies that demonstrated fully autonomous closed-loop control in fed-batch bioreactors producing Trastuzumab, a biosimilar candidate for HER2 breast cancer treatment. 

Basetwo AI, which builds agentic digital twin software for pharmaceutical and chemical manufacturing, successfully demonstrated predictive control of a bioreactor in the flagship initiative in collaboration with CPI, Labman, and Nicoya.  

The autonomous AI system successfully predicted glucose demand from cellular activity and automatically decided the feed timing and amount without human intervention. Using this approach, glucose levels were maintained at the target band without a spectroscopic probe. The autonomous control was successfully able to improve cellular viability and titer (yield) in comparison to manual control - which produced glucose-limited conditions in the reactor. 

The result addresses a common challenge in biopharmaceutical manufacturing and development: achieving continuous visibility and control of critical process variables (CPVs) without relying on additional analytical instrumentation or manual intervention.  

Today, many bioprocessing teams rely on periodic lab measurements to monitor CPVs like glucose, viable cell density and titer leaving operators without visibility between samples. While spectroscopic process analytical technologies (PAT) such as Raman and NIR can provide more frequent measurements, their adoption can be costly, requiring additional hardware, calibration, and ongoing maintenance. 

This collaboration demonstrates an alternative to manual sampling and costly instrumentation. By combining automated robotic sampling with autonomous AI closed-loop control, this approach offers a potential pathway for bioprocess teams to implement advanced control strategies using the infrastructure they already have. 

Philip Probert, Director of Biologics, RNA Centre of Excellence and Medicines Manufacturing Innovation Centre at CPI said:

The results show that closed-loop glucose control doesn't have to wait for slow, manual lab samples or spectroscopic probe, teams can start on the vessels and data they have available. This approach enables process development teams to rapidly screen multiple process setpoints, media types, and clones while holding glucose and process conditions stable without human intervention.