Advanced Technology for Cell Therapy Products
July 30, 2013DOTR supplies sensors for closed bioreactor systems
Since July 2013 DOTR is contributing to the Seventh Framework Project REACH with its know-how in chemical optical sensor technology. REACH aims at developing a novel bioreactor system for the medical sector - getting it to a pre-commercial scale - that shall advance cell therapy production processes for industrial or research applications.
The market for cell therapy products (CTPs) has great growth potential. Nevertheless, the widespread availability of such products is limited due to complex and difficult production processes. Specific equipment is needed for the production; especially closed systems for cell expansion are required.
Throughout the next three years three SMEs together with the Leiden University Medical Center (LUMC) will combine their expertise within the REACH project and create a novel bioreactor system for cell therapy. The system will consist of a disposable bioreactor bag with unique miniaturized disposable sensors, and shall be applicable for GMP grade production of mesenchymal stem cells (MSCs) outside a cleanroom. REACH follows the FP7 StemExpand project, which focused at the expansion and engraftment of hematopoietic and mesenchymal stem cells for clinical use. Results from this preceding project showed that a novel, closed, and controlled bioreactor can be developed to grow clinically relevant numbers of MSCs.
The Dutch company Xpand Biotechnology focuses on the development of closed bioreactor systems for 3D expansion of cells on the bench. Together with the LUMC the company will establish a process for expansion of GMP grade MSCs in this closed system. Cell culture control will be realized with sensor technology provided and created by DOTR and ABER Instruments. ABER is an expert in biomass measurement and will contribute with a miniaturized version of their established online biomass sensors. DOTR non-invasive pH and oxygen sensors integrated in the bioreactor bag will be connected to the reading and controlling devices by newly developed ports which allow easiest handling during set-up. DOTR will closely cooperate with ABER so the sensor systems work together and take account of each other. The transmitters reading the sensor signal will require special design so they can be integrated in the bioreactor platform and ensure accurate communication with the control unit.
When the set-up is ready for tests the LUMC will validate it in clinical settings. The quality of MSC production will be compared to GMP grade production according to an established protocol at LUMC. With the combined effort of the three SMEs and LUMC a new technology will be available to the medical sector, enabling to develop cell therapies in a faster, cheaper and more efficient way.
