The Essential Workstation for Cell Therapeutics
Continued worldwide development of new methods and processes in cell therapy and regenerative medicine requires renewed emphasis on tools and technologies required to establish and maintain aseptic conditions demanded of the clinical environment. Panasonic has met that challenge. In designing the industry’s first viable alternative to a conventional Class 10,000 cleanroom for both Class 100 air quality and barrier isolation, Panasonic has introduced the Cell Processing Work Station (CPWS) to bring the potential of cell therapeutics to more facilities while mitigating acquisition and operation costs and protracted time lines.
Immediate beneficiaries of the CPWS include both private and public institutions serving the life science, clinical, biotechnology and pharmaceutical markets. These include mainstream and scale-up pharmaceutical companies focused on drug and medical device development related to human cells, medical researchers applying cellular therapies in clinical trials, and hospitals now deploying FDA approved cellular therapeutics to treat a broad range of diseases. As the science progresses and results are propagated throughout the medical and scientific community, the need for bench-level research and production is expanding exponentially. As a result, the availability of the Panasonic free-standing, self-contained work station apart from the conventional layered cleanroom approach to containment and protection, is bringing the capability for on-site cellular therapeutics to more facilities more quickly and at a lower capital and operational cost, all within the GMP performance envelope required of the cell technology itself.
Self-Contained System, Small Footprint
The Panasonic concept of a self-contained work station is enabled by the company’s demonstrated proficiency for in situ decontamination required to separate processes from one protocol to another. By using a highly effective H2O2 decontamination process, the CPWS can be completely sterilized without heat and prepared for the next protocol within two hours as compared to a cleanroom decontamination function can take days or weeks. By increasing throughput within the parameters of GMP compliance and FDA guidelines, the CPWS is deployed for both research, cellular manipulation and growth, cell product extraction and emerging processes that fall within similar guidelines. Current and future applications of the CPWS include organ and tissue regeneration such as skin, cartilage, alveolar bone, cornea, cardiac muscle, nerve, liver and pancreas regeneration. Immunotherapy applications may extend to dendritic cells, T-cells and more. The relatively small footprint permits installation into existing or new Class 100,000 lab space with conventional utilities and minimal site preparation. Multi-layered airlocks in multiple treated rooms are avoided. Capital intensive expenses are lowered and lead times from decision to operation are shortened. Once in place, operational costs are highly contained and predictable, with sterilization available more frequently and at a fraction of conventional cost.
Improving efficiency in human interaction is a primary design attribute of the CPWS. All work must be performed without human error, in an aseptic environment, and with detailed documentation to assure quality and compliance. Gownup time, expense and inconvenience is minimized or eliminated altogether. Integrated systems within the CPWS permit cellular extraction, preparation, culturing with aseptic assurance as well as economic practicality.
Because conventional autoclaving is not possible, the H2O2 decontamination process diminishes both time and labor associated with this critical step between protocols, positioning the CPWS squarely in the equation for cost/ benefit justification associated with investment decision-making. Allowances for integrated centrifuge, microscopy, data acquisition and incubation functions are important considerations in the CPWS design; a unique docking station permits interface and exchange with unlimited number of cell culture incubators dedicated to individual cell lines.