Sanyo Biomedical is launching a cost-effective, space-saving stand-alone cell processing work station (CPWS) for GMP production.
CPWS reduces the investment and space needed to perform good manufacturing practice (GMP) compliant processing and manufacture of regenerative stem cells and cell therapies, according to Sanyo. This lowers the barriers to entry for biopharm, the public sector and academia.
Sanyo is marketing CPWS as a more compact, less expensive alterative to a traditional cleanroom. The stand-alone, self-contained unit features a four-port glove box and, when installed in a class 100,000 cleanroom, a class 100 environment within the workstation.
CPWS is 115” wide, 41” from front to back and 87.8” high. The smaller dimensions of CPWS, compared to a conventional cleanroom, increases flexibility when locating and orientating the unit, as well as contributing to easy acquisition and set up.
An integrated cell monitoring system helps reduce GMP floor space requirements. The unit includes a 19” LCD monitor to display real time images taken by a charge coupled device (CCD) camera with objective lens and phase difference filter.
CPWS is currently available in North America and Japan. A European launch is being planned, Deepak Mistry, strategic marketing manager at Sanyo told in-PharmaTechnologist.
Decontamination in situ
Operation of the self-contained workstation is underpinned by in situ decontamination. A H2O2 process is used to decontaminate CPWS without heat. This prepares CPWS for the next protocol within two hours, compared to days or weeks to decontaminate a traditional cleanroom.
Shortening decontamination time increases throughput, which contributes to lower operating costs. In a breakdown of potential operating costs Sanyo says CPWS has a nominal annual budget of $60,100 (€42,800), compared to $91,600 for a conventional GMP cleanroom.
Reduced expenditure on power consumption, validation of the cleanroom and report, and sterilised, non-shedding gowns contribute to lowering CPWS operating costs.