The role of single-use systems (disposables) in the development and manufacturing of biopharmaceuticals

摘要

As the number of biopharmaceutical molecules that are entering clinical trials is rising, there is increased demand for technologies that can expedite the commercialization process. Disposables or single-use systems constitute such an enabling technology. They are commonly used for inoculum expansion using wave rocking bioreactors that are available for working volumes of up to 500 L (1). More recently, stir tank disposable bioreactors have become available with working volumes of 1,000 L and even 2,000 L aimed at replacing small to medium scale stainless steel bioreactors (2). Preparation and storage of cell culture media and product purification buffers in disposable bags is another common application (3). Their use greatly reduces the need for piping, CIP and SIP infrastructure, and the consumption of cleaning materials (1). This in turn reduces the requirements for up-front capital investment and speeds up the commercialization process. The above attributes of single-use systems make them particularly attractive to start-up companies that are short in capital and are under pressure to meet development milestones.