ABSTRACT
With increasing yields, smaller budgets for development, and increase in the diversity of development projects, the future of bioprocessing rests on the adoption of smaller-size bioreactors that would be scalable but also flexible in their size, capabilities, and regulatory compliance. The cost of operating a 10,000 liters bioreactor is well established; unfortunately, it is not cost-effective to operate it at a smaller than minimum level. The validation of disposable systems has not been put to the real test yet where a regulatory agency would provide approval of a product manufactured using disposable systems. As disposable components found their way from downstream to upstream, from filters and buffer preparation to bioreactors, equipment suppliers developed their own standards and specification of things such as tube connectors, rating of sterilizing filters, and, above all, the composition of films. Molecule-specific facilities and equipment will prove to be more cost-effective than using a disposable system.
