BioCision, LLC has announced a collaboration with the University of California, San Francisco Transplantation Research Laboratory of Dr. Qizhi Tang, who is researching a novel transplantation immunotherapy that could potentially minimise rates of organ rejection and the toxicity of global immunosuppression; a similar strategy is being investigated for the treatment of autoimmune diseases including type 1 diabetes.

Dr. Tang’s research group, along with colleagues at the UCSF Diabetes Center, developed a cellular therapy that uses cells from the organ donor to activate the recipient’s regulatory T cells (Tregs). The stimulated Tregs are reintroduced into the recipient to enhance the acceptance of the new organ and minimise the patient’s dependence on immunosuppressive drugs. Manufacturing Tregs for clinical use is complex, and the UCSF team needed help to streamline and standardise the process. The research team became beta testers for BioCision’s CoolCell cell freezing technology and ThawSTAR, an automated cell thawing instrument. The team compared the use of the BioCision technologies with previously established procedures and provided data and feedback to BioCision. The researchers found that by incorporating BioCision’s CoolCell and ThawSTAR products into various steps of the manufacturing process they could increase the number of viable cells produced and reduce variability.

“We are encouraged that, through our research, organ transplant recipients may be able to achieve better organ acceptance and be spared the necessity of lifelong immunosuppressive therapy and the related side effects,” said Dr. Tang, associate professor in the department of surgery at UCSF.

“When manufacturing a cell-based therapy, we are dealing with live therapeutics and it is imperative that the most stringent controls are in place to enable predictable outcomes during each step of the process. We replaced our previous methods of freezing and thawing cells at multiple points in our workflow with BioCision’s CoolCell and ThawSTAR technologies to improve cell recovery and viability, as well as develop greater consistency. The products can also be easily transferred from our research phase to clinical manufacturing for our upcoming clinical trials. We intend to reference the FDA-accepted Device Master File (MAF2643) for ThawSTAR automated cell thawing system in our GMP manufacturing protocol documentation where applicable.”

BioCision is working with Dr. Tang’s lab in the following ways: development of a video describing how CoolCell and ThawSTAR products were integrated into a Treg GMP clinical manufacturing workflow; a joint trip to Japan and Korea where Dr. Karim Lee, a researcher in Dr. Tang’s lab, presented the lab’s studies related to CoolCell modules and the ThawSTAR system with researchers in those countries; validation of the ThawSTAR system at UCSF’s GMP cell manufacturing facility, headed by Florina Dekovic, Quality Assurance Manager of the facility; sponsorship of the first Global Virtual Laboratory (GVL) workshop organised by The Transplant Society at the 14th Transplantation Science Symposium in Australia. The GVL is aimed at educating transplantation researchers on approaches and techniques of immunological studies using human cells.

“The opportunity to work with leading researchers like Dr. Tang and see our technologies used in potentially life-saving cell therapies reinforces our commitment to bring innovative tools to the life science community,” said Dr. Rolf O. Ehrhardt, CEO of BioCision.

“Our focus on standardisation technologies enables a rapid transition from research and development to clinical manufacturing, and has the potential to bring new therapies to market faster.”

CoolCell controlled-rate cell freezing containers provide consistent and highly reproducible -1 degree Celsius per minute cell cryopreservation with high rates of recovery and viability, replacing conventional methods such as alcohol-based passive freezing, which can be variable and incorporates a hazardous solvent into the process, and programmable controlled-rate freezers, which are expensive and difficult to maintain.

The ThawSTAR automated cell thawing system is a breakthrough technology BioCision developed to replace insufficient manual thawing methods. The system standardizes each step of the thawing process from the point at which the vial is removed from cryogenic storage. The one-step intuitive design integrates proprietary algorithms and adaptive sensing technology to customize the thaw for each vial and provide a standardized and reproducible thawing method with high post-thaw recovery and viability.

“We have found that using CoolCell and ThawSTAR products in our workflow has provided several advantages for our research. The CoolCell is very easy to adopt in that it requires no maintenance and provides results as good as our expensive controlled-rate freezer,” said Dr. Karim Lee.

“We were fortunate to be beta-testers and early adopters of the ThawSTAR system because our previous method of hand-carrying frozen vials and then swirling them in warm water baths was very difficult to control, especially as we moved out of the R&D phase and into GMP clinical manufacturing.”