Cell and gene therapies (CGT) are becoming an increasingly viable therapeutic alternative to traditional treatments for many diseases, such as cancer, yet the complexities of the manufacturing process and the high cost of treatments present a significant hurdle in meeting patient demand. Patients in need would benefit from improved access and reduced wait times to improve treatment efficacy.
Reducing manufacturing costs, lowering wait times and increasing supply requires transitioning away from manual protocols and towards adaptive process strategies. Automation can significantly diminish the need for human intervention and errors, improve process robustness and increase throughput.
A robust, fast and cost-effective production process is crucial for the effectiveness of cell therapy. It necessitates integrating Process Analytical Technology (PAT) solutions with automated cell therapy manufacturing systems. We have been meeting the need for PAT devices with our bioprocessing suite of products, including MAVEN and MAVERICK, to help advance cell therapy manufacturing and deliver real-time insights to help get life-saving treatments to patients faster.
MAVEN offers on-line monitoring and control of glucose and lactate concentrations during cell culture processes, operating without having to manually draw samples out a bioreactor. Similarly, MAVERICK is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.
MAVEN and MAVERICK integrate with cell therapy manufacturing systems and deliver continuous monitoring and control of critical process parameters (CPPs), such as glucose and lactate. As a result, manufacturers can enhance their understanding of the process, take quick course correction and ultimately, lower costs.
As a recent example, we announced our collaboration with Terumo Blood and Cell Technologies (Terumo BCT). By combining MAVEN with Terumo BCT’s Quantum Flex cell expansion system, cell therapy manufacturers can monitor and control glucose and lactate concentrations in cell cultures in real time without having to enter the clean room and perform manual bioreactor sampling. Doing so reduces the risk of contamination, saves time and improves process understanding. Combining these automation technologies provides insights into and control of cell expansion, one of the largest components of cell therapy development and manufacturing. Our article co-authored with Terumo BCT, published in American Pharmaceutical Review, highlights the importance of real-time analytics for enhanced process understanding.
We also announced a development collaboration with Cellares to integrate our MAVERICK in-line analyzer into Cellares’ Cell Shuttle system, a fully integrated, scalable, cell therapy manufacturing platform. MAVERICK provides real-time monitoring of the cell culture process, enabling the Cellares team to take immediate corrective action. In-line analysis also maintains sample integrity, reduces contamination risk and improves product quality. Our collaboration with Cellares aims to make advanced cell therapies more accessible and affordable for patients who need these critical life-saving treatments.
This industry is ripe for innovation and more developments are on the horizon, as evidenced by the recent FDA approval of the first ever cell therapy for solid tumors. Learn more about how we are working to overcome manufacturing challenges in cell therapies.