SANYO North America Corporation (SANYO) Biomedical Solutions Division announces that its Cell Processing Work Station (CPWS), an integrated, stand-alone solution for GMP compliant processing and preparation of regenerative stem cell and cell therapies for research use, has been installed at the University of Alabama at Birmingham (UAB) as the nation’s first installation of the CPWS, as well as marking SANYO’s first to be installed outside of Japan. The workstation provides the required class-100 aseptic environment in a compact footprint and at a lower cost than a traditional cleanroom. The type of CPWS installed at the university is a positive pressure system, which will aid the school in its research into gene and cellular therapies. A negative pressure CPWS is in development.
Christine Stannard, Vice President of the Biomedical Solutions Division, commented, “In order for the cell therapy market to grow, research of stem cell and cell therapies will become a critical step, and SANYO is providing a practical solution for biotech and pharmaceutical customers to advance their research.” She added, “UAB will have the latest technology available to them now as they move further into the research that will support this growing market.”
The small footprint of the CPWS allows installation into existing or new lab spaces using conventional utilities and minimal site preparation. While offering a highly efficient operational capacity, the workstation includes GMP compliant equipment for aseptic processing and provides user-friendly operation controls. Capital costs for acquiring the CPWS are substantially lower than the cost of constructing a new cleanroom. In addition, the SANYO CPWS also saves approximately 35% of the operating costs usually required for conventional cleanroom environments.
As the cell therapy market is set to expand, the CPWS will make a significant contribution to advancing research in the cell therapy market, impacting both private and public institutions within the life science, research, biotechnology and pharmaceutical markets. Current and future applications of the CPWS include preclinical regenerative cell therapy research for organ and tissue repair and immunotherapies for treating cancer. Additional opportunities for the CPWS include the pharmaceutical bioprocessing market.
The nation’s first CPWS installed at the University of Alabama at Birmingham, will be used to manufacture induced pluripotent stem (iPS) cells and gamma-delta T cells for research use. iPS cells are non-embryonic stem cells that will be studied as a cure for sickle cell anemia. Gamma-delta T cells will be studied for treating cancer. The CPWS offers UAB enhanced biosafety and enhanced aseptic processing for the GMP compliant manufacture of these and additional cell therapy research.
“The CPWS allows seamless preparation of cell and gene therapy products in a totally contained temperature controlled aseptic environment, drastically reducing the risk of microbial contamination,” said Larry Lamb, Ph.D., director of the UAB Cell Therapy Lab, which houses the SANYO CPWS. “The technology also features the ability to change over the entire system in 90 minutes allowing for multiple cell products to be produced in a single CPWS. The Cell Therapy Laboratory and the UAB Stem Cell Institute envision a variety of therapies that can be derived from iPSc, hence we anticipate that the CPWS will serve this need well into the future.”
UAB has been a national leader in the field of therapeutic design for nonmalignant diseases of the blood, such as sickle cell disease, using both conventional gene therapy and iPSc-derived approaches. Additionally, UAB is among the most active programs in North America for translation of gamma/delta T cell-based therapies of cancer, anticipating the first clinical trials in brain cancer and in leukemia in one to three years. The newly opened UAB Cell Therapy Laboratory will support these UAB-based research activities, as well as lead to several industry-based clinical trials in the near and distant future.
Source: SANYO North America Corporation (SANYO) Biomedical Solutions Division