Assessment of the biological contamination risks depending on the design of aseptic environment in cell manufacturing

Abstract

Background & Aim Aseptic processing is one of the most important issues in the production of cell-based products which are handled by opening the culture vessels. The practical level of aseptic processing depends on the design of aseptic environment where the equipment for research are installed in the cell manufacturing facility. An aseptic environment where biosafety cabinet (BSC) is installed as the aseptic processing area (Grade A) has vulnerability due to manual operations crossing between aseptic processing area and its surrounding area. Though robustness of an aseptic environment where isolator system is installed is much higher than that in the BSC, the facility cost of the isolator system may be more expensive. On the other hand, the facility with BSC has more lot out risks in production due to biological contamination, resulting in higher manufacturing cost. When the cost of goods for a cell-based product is calculated, it must be considered adding on the required resources with the failure probability of cell manufacturing caused by biological contamination. Methods, Results & Conclusion In this study, biological contamination risks depend on the design of aseptic environment construction has been assessed by introducing the method of work breakdown structure (WBS). Then the failure probability of cell manufacturing caused by biological contamination was simulated with consideration of the possibilities which is based on the particle contamination in the product depending on the equipment usage in facility. It is expected that the established assessment model will be useful for design of cell manufacturing facility.