During the past decade, single-use bioprocessing has emerged as a standard platform for current goodmanufacturing practice (CGMP) mammalian cell culture. Biomanufacturers have come to appreciate the benefits of lower capital and operating costs, reduced contamination risk, continuity from early development through manufacturing, flexibility, and sustainability (1).Disposable cell-culture vessels have gained wide acceptance because their performance duplicates that of stainless-steel, fixed-tank bioreactors, with which manufacturers have extensive experience. This is no accident: Single-use bioreactors use stainless-steel engineering principles, particularly with respect to impeller rotation speed, agitation and aeration rate, reactor geometry, and so on. Retaining critical physical characteristics enables predictable, relatively problem-free transitions from stainless to single-use bioreactors.
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