For almost 40 years, bioprocess engineers have been
indoctrinated with the technology of the stirred tank
bioreactor. But many have concluded that a plastic bag can be
effective and that the results achieved with cultures in a
single-use bioreactor are comparable with the results achieved
in the glass or stainless-steel stirred tank bioreactor. This
article describes experiments performed in the bag type single-
use bioreactor that suggest it can yield results that are
comparable with those as achieved in the traditional stirred
tank bioreactor. An increasing number of therapeutic candidates,
including monoclonal antibodies, biotherapeutic proteins, and
vaccines, are currently entering early-stage process
development. At the same time, biologics are being introduced
onto the market or have recently been introduced. In this
competitive market, time-to-market, cost-effectiveness, and
manufacturing flexibility are key issues that all must be
achieved while maintaining product quality. Traditionally
stirred tanks,