Minimizing Organ Rejection Rates
Industry Insight Nov 16, 2015
BioCision recently announced a collaboration with the UCSF Transplantation Research Laboratory of Dr. Qizhi Tang. Dr Tang's research is focusing on a novel transplantation immunotherapy that holds the potential to minimize rates of organ rejection and the toxicity of global immunosuppression. The partnership aims to standardize critical steps in the manufacturing workflow through leveraging BioCision’s CoolCell and ThawSTAR technologies.
To find out more about this exciting collaboration we spoke to Dr. Rolf O. Ehrhardt, PhD, CEO of BioCision.
Dr. Rolf O. Ehrhardt (ROE): After transplantation, immunosuppressants must be taken every day to prevent the recipient's body from injuring the transplanted organ by a process called rejection. Organ recipients who take these drugs may experience side effects such as infections, delayed wound healing, higher cancer risk, headaches, nausea, and vomiting. Minimizing or eliminating the current dependence on immunosuppressants may lead to lower risk of severe side effects and better quality of life for organ recipients, especially children, who could potentially take immunosuppressants for a longer period of time than older recipients.
AB: Can you explain how your cellular therapy reduces this dependence?
ROE: Studies show that some white blood cells, called regulatory T cells (Tregs), may play a part in allowing the body to accept the transplanted organs and cells. The investigators are learning about whether scientists can take Tregs from the blood of an organ transplant recipient and teach them to protect the transplanted organ from rejection. In the laboratory, the recipient Tregs are exposed to cells from the donor. These "donor reactive" Tregs can recognize the transplanted organ, but instead of rejecting the organ, they protect the graft by blocking the cells that harm the organ. Research data shows that giving these "donor reactive" Tregs back to the transplant recipient allows an organ transplant recipient to take lower doses of immunosuppressants, or even stop them altogether, without rejecting the organ.
ROE: Producing cells for clinical use is a strictly controlled process to ensure high quality cells are consistently produced for every patient. Equipment that performs reliably and is simple to use is much desired. BioCision’s CoolCell® cell-freezing containers were used to accomplish controlled-rate freezing of the organ donor’s and recipient’s cells as raw materials for manufacturing ‘donor reactive” Tregs. BioCision’s ThawSTAR™ Automated Cell Thawing System and CFT Transporter were used to thaw cells during the manufacturing process. The CoolCell® platform performs similarly to an electronic controlled rate freezer, the gold standard for consistent cryopreservation of cells with regard to viability and recovery. The CoolCell® platform is far less expensive than the previous method, does not contain liquid solvents, is easily transportable and can be acclimated quickly for a fast turnaround time between freezing batches. The ThawSTAR™ System is generally comparable to or better than a water bath, a standard equipment for thawing cells. Water is problematic in a GMP facility because of its tendency to have microbial growth. The ThawSTAR™ is low maintenance, water-fee, transportable and easy to clean, and therefore this cell thawing platform can be incorporated into a GMP facility for clinical manufacturing.
AB: How important is standardization in bringing therapies from research and development to clinical manufacture?
ROE: Standardization of cell handling processes is an important component of Good Manufacturing Practice (GMP) related to clinical manufacturing of cellular therapy products. As GMP components are relevant to most, if not all, applicable cellular therapy regulations in the U.S., EU, Japan and other global regions, academic and industry organizations are focusing on standardizing their cell handling practices as they actively seek to move their research findings into the development of treatments to address unmet patient needs.
Dr. Rolf O. Ehrhardt was speaking to Ashley Board, Managing Editor for Technology Networks.