Barriers to Use
If single-use biomanufacturing facilities are to continue replacing traditional fixed plants, there are a number of technical, environmental, and logistical hurdles to overcome. Currently, many single-use biomanufacturing facilities do not have the capacity for large-scale production of biologicals or vaccines.
“The scale that single-use technologies are being operated at is increasing all the time,” Ross noted. Cell culture used to be a bottleneck; now 2,000 L bioreactors are available. Flow rates through disposable assemblies used to be an issue due to the dimensions of aseptic connectors that were previously available, but this has been addressed now. One of the current issues is the pump capacity available in a single-use format, but even here technologies are becoming available that allow for flow rates up to 400 L/min for running microfiltration and ultrafiltration applications.”
Another obstacle that requires a shift in perceptions and more research is the environmental impact of implementing a single-use biomanufacturing facility. To date, a life cycle assessment (LCA) comparing energy demand and global warming potential of stainless steel and single-use bioreactors carried out by GE Healthcare in conjunction with Biopharm Services showed that at a range of production scales single-use bioreactors utilize up to 43% less energy.
“Using disposable bioreactors is not like eating off paper plates every night because the amount of energy and water you’d use to clean a plate is negligible,” Royce commented. “However, when you’re talking about cleaning a bioreactor, the amount of energy to produce the steam to clean it and the amount of water you not only use to clean it but also produce as effluent is much greater then even we’d realized.
“This is why we were pleasantly surprised to see single-use bioreactors actually scored better than their stainless steel counterparts on all 18 environmental factors we evaluated.” This is good news for bioprocess scientists, and the LCA referenced in this article makes similar comparisons of energy demands of an end-to-end single-use process.
Additionally, companies that want to implement a single-use biomanufacturing facility may have difficulty sourcing all of the component parts. This may hold up production runs.
“Pharma and biotech companies are looking to the suppliers of single-use products to ensure each component is delivered on time, are traceable by RFID tagging, are fully validated, and all the leachable and extractable data of each plastic is supplied, too,” Ross said. This shifts the onus onto vendors to ensure their supply chains and logistics are really up to scratch, and this level of reliance requires a real shift in mindset for bioprocess scientists.”
With future trends in the biopharma industry such as generating monoclonal antibodies that are more potent and the rise of personalized medicine allowing smaller patient populations to be effectively treated, large-scale production of monoclonal antibodies may become less necessary. If this is the case, single-use end-to-end biomanufacturing facilities could become a much more popular manufacturing model in the next decade.