COVID-19 was a tipping point for single-use systems (SUS) with demand for the disposable and flexible technology for commercial-scale manufacturing increasing significantly. And, according to researchers, how suppliers catered to this sudden surge will shape the SUS market for years to come.
This conclusion is presented in a new paper by scientists at GSK and the Advanced Center for Biochemical Engineering at University College London, which looked at how SUS have impacted drug manufacturing over the past two decades.
The key finding is that while use of SUS has increased since the launch of the Wave Bioreactor in 1996 and the Hyclone stirred-tank bioreactor in 2004, application was focused on R&D, process development, and trial supply rather than on commercial manufacturing.
According to the study, a majority—71.2%—of drug companies up until recently used SUS in upstream R&D operations, whereas only 36% of biopharmaceutical companies used SUS in commercial manufacturing.
Then, during the pandemic, everything changed. The need to quickly mass produce vaccines against the SARS-CoV-2 virus saw biopharmaceutical companies reaching for flexible technologies that could be brought online quickly.
“The current coronavirus disease pandemic and the requirement for rapid large-scale vaccine production have caused a surge in demand for single-use systems,” the authors write. “The modular nature of SUS has enabled local manufacturing in developing countries, unable to afford major investments in stainless steel facilities, to support their own domestic and regional markets.”
Supply chain shortages
Another impact on the increased use of single-use tech—beyond the availability of COVID-19 vaccines—was the development of shortages. The authors cite commodities such as high-purity polymers as some of the components that were in short supply after the pandemic hit. Since then the single-use sector has worked to add capacity.
According to the authors, 60% of single-use technology suppliers said the increased COVID-19–related demand led to much more rapid and widespread expansion in commercial manufacturing capacity for SUS, along with increased funding.
The surge in the use of single-use technologies also made clear there are certain areas in which the technologies need to improve. There is, for example, little standardization in such systems. Technology from one supplier can differ markedly from an equivalent platform from another firm. While this allows for novel configurations, some standardization would help industry, the authors say: “Ancillary equipment, for example, connectors, tubing, valves, and sensors, would hugely benefit from standardized geometries and connections to improve plug-and-play between various vendors, especially in times of supply chain constraints, such as during the coronavirus pandemic.”
The researchers conclude that use of single-use tech for commercial production will continue to increase as the systems continue to develop.
“With the wide plethora of advantages that they bring to the industry, SUS have a bright future in traditional mAb and vaccine production, for emerging cell and gene therapy products, antibody drug conjugates, and in epidemic/pandemic manufacturing scenarios,” say the scientists. “To reach the full potential of SUS, the industry still needs to carry on tenaciously driving innovation as well as standardization efforts. Innovative studies in new sensors and novel materials are urgently needed.”