It is hardly surprising, therefore, that there has been widespread adoption of single-use technologies throughout the industry over the last five years. Over this period, single-use technology has extended beyond single-use bags, transfer sets, and membrane filters. The industry has seen rapid advances in the offering from suppliers with respect to processing, monitoring, and sensor equipment. There has also been a fundamental change in the business models of some suppliers, where the primary focus has switched from capital equipment to single-use consumables.
Such has been the rate of progress; the industry has developed to a point where, for some product areas including mammalian secreted proteins and viral products derived from mammalian or insect cell lines, it is possible to build processes entirely from single-use technologies.
The use of the technologies within the CDMO industry has brought about a change in CDMO business models, with a move away from seeing plant and facilities as the selling asset, to one where flexibility and speed are the major drivers with companies focusing on product areas to which single-use technologies can be applied.
Initial capital outlay is lower as a result of more simplistic and standardized designs. In addition, there is a large reduction in design, procurement, and validation costs. Reduced equipment lead and installation times mean that decisions on expenditure do not need to be made as far in advance of facility requirements, reducing business risk.
Returns on capital outlay can be achieved in shorter time frames, which is critical if the equipment has been purchased with borrowed capital. Finally, the simplification of installation processes and the reduction in validation times within manufacturing suites reduces lost manufacturing capacity.
One of the greatest impacts of single-use systems has been on facility turnaround and cleaning; the decreased need for cleaning and the availability of items such as pre-packed chromatography columns, bioreactors, and filtration systems reduces process set-up times and the need for equipment turnaround during production. The facility clean-down at the end of the process may be no more than a line clearance, and the elimination of the need to demonstrate product removal from product-contacting equipment represents a huge savings in time and effort.
The impact of the adoption of single-use technologies is not limited to the equipment used to perform the manufacturing operation. A number of case studies have been presented for the development of facilities based solely on the use of single-use equipment. In some cases facilities have been designed on the premise that buffer and media will be procured and the facility therefore requires no water or steam systems, representing extensive cost savings.
The concept of regarding single-use systems as closed systems leads to the potential for performing manufacturing processes in grade D (Class 100,000) areas compared to grade C (Class 10,000), which has the potential to further reduce operational costs.