Product News: SANYO Introduces Industry’s First Stand-Alone Cell Processing Work Station Transforming the Biomedical Cleanroom

22 Oct 2010

SANYO North America Corporation announces that its Biomedical Solutions Division is moving to the forefront of the stem cell and cell therapy market with the introduction of the industry’s first integrated, stand-alone Cell Processing Work Station (CPWS).

Offering a turnkey and standalone solution, SANYO’s CPWS is an innovative, cost effective and space-saving solution for the GMP compliant processing and manufacture of regenerative stem cell and cell therapies. The CPWS lowers barriers to enter the cell therapeutics market, positively impacting both public and private institutions. The workstation provides the required class-100 aseptic environment, but in a compact and less expensive than a traditional costly and large footprint cleanroom.

The cell therapy market is increasingly playing an important role in the practice of medicine, and the number of companies and entities that are involved in cell therapy are on the rise, including academic institutions, and public and private companies. The market is expected to expand over the next decade, with applications for the technology to include cancer, cardiac and genetic disorders as well as wounds of the skin and soft tissues.

“SANYO is prepared to expand into this rapidly growing market with its new Cell Processing Work Station, which will provide a practical solution for its biotech and pharmaceutical customers to develop and manufacture advanced cell therapies and hospitals to develop cell therapies for use in clinical trials,” stated Ron Dudek, New Business Development Manager.

The CPWS is a stand-alone, alternative to a traditional cleanroom, and the station is a self-contained system with a small footprint that is quick and easy to install. Offering a highly efficient operational capacity and featuring a contamination-free design, the workstation includes cGMP compliant equipment for aseptic processing and provides user-friendly operation. The SANYO CPWS also saves approximately 35% of the operating costs usually required for conventional cleanrooms (open systems).

The CPWS significantly lowers barriers to entry to the cell therapeutics market, which will impact both the private and public institutions within the life science, clinical, biotechnology and pharmaceutical markets. Current and future applications of the CPWS include regenerative organ development, tissue regeneration such as skin, cartilage, alveolar bone, cornea, cardiac muscle, nerve, liver and pancreas.

Main Features of the CPWS
Self-Contained System, Small Footprint
The small footprint permits installation into existing or new lab spaces using conventional utilities and minimal site preparation. The CPWS individual docking incubators reduce product mix-up and cross-contamination errors. An optional built-in centrifuge and cell observation microscope/monitor further reduce laboratory space requirements as well as improve aseptic processing.

Higher Efficiency
By using a highly effective H2 O2 decontamination process, the CPWS can be completely sterilized without heat and prepared for the next protocol within two hours instead of the conventional cleanroom decontamination protocol that can take days or weeks.

Contamination-free Design
The four-port glove box delivers more than a conventional Class II, Type A2 biological safety cabinet typically installed within a cleanroom to achieve the same level of contamination or cross-contamination prevention. Centrifuge and incubator access from within the Class 100 work station environment enhances aseptic processing.

Other Key Features
- Approximately 35% less expensive to operate than a conventional cleanroom (open system).
- The barrier isolator creates a grade A or class 100 environment within the workstation. (When installed in a class 100,000 cleanroom).
- Gowning is not required, allowing for a significant improvement in user comfort and productivity upon entrance and exit from the aseptic environment.