High-Quality, High-Efficiency Automated Cell Processing Robot System Developed for Regenerative Medicine

Tokyo March 15, 2010 — Kawasaki Heavy Industries, Ltd. and the National Institute of Advanced Industrial Science and Technology (AIST) announced today that they have developed an automated cell processing robot system, the "R-CPX: Robotized – Cell Processing eXpert
  system," for the growing field of regenerative medicine. It is a high-quality, high-efficiency device that is fully automated and can process cells from plural donors simultaneously.

Regenerative medicine, which uses cultured cells and tissues to regenerate organs and tissue functionality lost through illness or injury, is at the forefront of medicine. Current cell culture uses GMP-based^*1 cell processing centers (CPCs)^*2 where highly skilled technicians work by hand. In order to prevent cellular contamination and the cross contamination of one donor's cells with another's, any given room is restricted to culturing a single donor's cells. A limited ability to culture cells has been a major impediment to the further development of regenerative medicine.

This newly developed system is fully automated, using two clean robots in tandem to mimic the complex work of skilled technicians, and maintains a sterile environment inside the device using vapor-phase hydrogen peroxide sterilization. The result is high-quality, high-efficiency cell processing capable of handling the cells of plural donors simultaneously. In addition to its cell processing functions, the system also incorporates a human interface that allows hands-on work within the device, thus broadening its range of use. It not only has an automated determination feature that utilizes image processing to judge the state of cultured cells and remote monitoring to support user operations, but also supports production management techniques developed at the manufacturing facility, flexible culture scheduling and cell history management, and other features suited to the needs of medical facilities.

The development was carried out under the Translational Research Promotion Project “Development of medical treatment and culture system to establish the world standard quality of regenerative and cell medicine” commissioned by the New Energy and Industrial Technology Development Organization (NEDO). Associate Professor Wakitani of the Graduate School of Medicine, Osaka City University was a project leader, Professor Tahara of the Institute of Medical Science, the University of Tokyo was a project sub-leader, and Kawasaki Heavy Industries, Ltd. and AIST were contractors, while Osaka City University, the University of Tokyo, Shinshu University, the National Center for Child Health and Development, and Matsumoto Dental University served as joint research institutions. The project lasted two-and-a-half years, from September 2007 to February 2010, and focused on cell culture as an essential part of both regenerative medicine and gene therapy. Following evaluation and testing of a prototype, it led to the development of this automated cell culture robot system.

*1 GMP (Good Manufacturing Practice): Standards that govern pharmaceutical and quasi-pharmaceutical product manufacturing and product quality so that products are manufactured at the same, high level of quality regardless of the individual who manufactures them. In clinical research, it is required to meet GMP standards set by research institutions.

*2 CPC (cell processing center): A “clean room” to culture cells used in medicine. The processing room is a class 10,000 clean room (in which the number of particles (pollutants, dust, etc.) of size 0.5 µm or larger is less than 10,000 particles per cubic foot of air) and individuals wear clean room clothing. In the processing room, culture vessels are handled inside a class 100 safety cabinet (or clean bench) that is kept sterile.