Disclosed is a single-use
bioreactor bag design providing substantially equivalent maximum
shear rate at the
impeller tip and average or bulk
shear rate over a range of power per unit working volume and rpm needed for bioculture
processing. The uniformity in shear profile of the bag design providing a unique
advantage when used as a scale-down or scale-up platform. Also disclosed is a linearly scalable, single-use,
bioreactor system for use in carrying out a scalable
biomanufacturing process, the
system comprising two single-use
bioreactor bags of different volumes, wherein the ratio H / D of the height of the working volume H to the
diameter D of the tank, or of the bag is equal to about 1.5, and the bulk shear in each of the bags is substantially constant. The disclosed small scale
system models larger scale systems from both a shear /
scalability / performance basis and also from a validation and regulatory basis. In summary, the 10 L bioreactor system disclosed provides for “linear
scalability” by using the same or substantially simulating the same vessel geometry, gas sparging system,
impeller shape and type,
polymer composition of the flexible bag / components,
process control system, and shear rates as larger 50-5000 L systems.