By Matthew Olsen
Single-use systems consisting of bags, tubing, filters and other connecting components have now been in use in the biopharmaceutical industry for over 25 years. There are nearly no areas of the process where at least one single-use solution does not exist to provide the many conveniences which disposable, pre-sterilized components can enable. The quick turnaround times, reduced capital costs and significantly reduced validation costs associated with single-use technologies have now been fully embraced by the industry and are well illustrated by the speed of adoption these technologies have enjoyed. New entrants to the industry are now able to benefit from a “Single-Use First” business plan and avoid the costly buildout of a fully stainless steel reusable plant. The disruptive advantages this confers are analogous to the advantages in telecom buildout speed and cost that have been achieved in the developing world through the use of mobile phone technology to completely leap-frog the need to build out expensive wired telecommunications infrastructure. The adoption of single-use in combination with the prevalence of Contract Manufacturing Organizations (CMO) can result in a significant reduction in the timelines and up-front investment required to bring a novel therapeutic to the clinic and the market.
Although their adoption has been swift and unit operations which were formerly groundbreaking are becoming commonplace, the familiarity and experience of end users with the available products is in turn leading to a grassroots demand for new advancements in the science and technology of single-use bioprocessing. These demands have been expressed, for instance, by the BioPhorum Operations Group (BPOG) community which has published a number of documents representing a set of explicit requests and roadmaps developed by end users for advancements in biopharmaceutical production, some of which provide feedback on single-use technologies.
This article will discuss four topics related to single-use bioprocessing which are commonly cited by end users as amenable to future development. These concepts are key to the future of single-use systems in the midst of the current paradigm shift to the 100% single-use bioprocess: