ABSTRACT
One major change in the design of bioreactors that is recent is the use of disposable bioreactors to avoid the challenges of cleaning validation, thus reducing the regulatory barriers in drug production. Disposable bioreactors have varied designs and purposes but all of them are made of Class VI plastic films, are sterilized by gamma radiation, and are disposed of after use. Disposable bioreactors come in many sizes, from milliliters to thousands of liters; they can be equipped with bioinformatics systems that range from very simple to very complex. It is assumed that the pharmaceutical industry’s current drive toward safe, individualized medicines (e.g., personalized antibodies, functional cells for cancer, immune and tissue replacement therapies) will contribute to the continuing growth of disposable bioreactors. Controlling and mitigating the negative interactions enabled the routine utilization of disposable bioreactors for the cultivation of cholesterol-dependent NS0 cell lines in conjunction with an animal-component-free cultivation medium.
