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 wide recognition of these advantages is best 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 in a situation analogous to the disruptive advantages 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. This advancement in combination with the prevalence of CMO’s can result in a significant reduction in the timelines and up-front investment required to bring a novel therapeutic to the clinic.
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 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.
There are four areas of understanding which are commonly cited by end users as amenable to future development. These concepts are key for the future of single-use bioprocessing as we move to an industry focused on the paradigm of the 100% single-use bioprocess:
- Increased Understanding of Biocompatibility
- Improved Integrity Assurance for Single-Use Systems
- Integration of Single-Use Measurement and Automation to support PAT efforts
- Development of a Resilient Global Supply Network