Disposable vs. Traditional Equipment — A Facility-Wide View

Single-use/disposable technology (SU/DT) has emerged over the past decade as a cost-effective and fl exible basis for biopharmaceutical manufacturing (1,2). It has moved beyond the limited applications of culture bags, liquid storage bags, and sampling devices, and now includes more unit-operation-based capabilities, such as cartridge fi ltration, depth fi ltration, ultrafi ltration, and chromatography. Biopharmaceutical manufacturing typically involves a limited number of similar unit operations and processes — the primary differences among processes being the number, size and sequence of the unit operations. However, the facilities are large, complex and capital-intensive, with multiple interacting systems and operational preferences, so making comparisons between SU/DT and traditional systems is diffi cult and subjective. Such an evaluation, therefore, needs to take a whole-facility approach. Toward that end, this article considers a model process carried out in a small-scale biotechnology manufacturing facility designed to maximize SU/DT, and compares that to a facility designed around traditional reusable technology. For each unit operation, an acceptable commercially available SU/DT option that has adequate capacity and is suffi ciently well-developed to support commercial manufacturing is determined. The utility requirements and capital equipment costs associated with a SU/DT-based facility are then estimated and compared with those of a traditional manufacturing plant. The results of the analysis suggest that, for a facility designed around a 1,000-L production-scale bioreactor, most unit operations can be based on SU/DT, which largely eliminates the need for clean-in-place (CIP) systems. This is accompanied by a signifi cant reduction in the facility’s water consumption and waste generation. The primary reduction in capital costs is associated with process liquidhold applications, such as intermediate product hold, media hold, and buffer hold steps.