Making drugs for smaller patient populations is challenging in plants designed for volume production. Instead, to make the economics of small-scale manufacturing work, industry should embrace on-demand technology.
In biopharma—like in the traditional small molecule pharmaceutical sector—manufacturers have sought to reduce the cost of making individual products by intensifying output and centralizing operations in large-scale facilities. But while this approach makes sense for mass market medicines, it does not work for low-volume or patient-specific products, says Zhuojun Dai, PhD, professor at the Shenzhen Institute of Synthetic Biology in China.
“Current standard manufacturing models aim to produce biologics at large scale and are generally optimized for fed-batch bioreactors, followed by a combination of different filtration and chromatography unit operations to achieve the required purity and yield,” Dai notes. “These centralized approaches rely on infrastructure and large facilities,” explaining that the fermenters and chromatography columns used in traditional biopharmaceutical manufacturing and expensive and require a significant amount of space.
Furthermore, she says, traditional centralized manufacturing usually requires specialized transportation equipment and refrigeration technologies which are also expensive and energy intensive.
For firms developing small volume and patient-specific products investing in such facilities and infrastructure does not make economic sense, according to Dai, who points to decentralized, on-demand production as a workable alternative.
“On-demand manufacturing is a method of producing the required products only when they are needed and in quantities required,” she continues, adding that “by its very nature on-demand manufacturing should de-centralized and even portable.”
Dai and colleagues analyzed the on-demand manufacturing concept in a new study and concluded that recent advances in bioprocessing systems have given companies interested in low volume production the tools they need.
“We discussed a series of recently developed technologies, such as cell-free protein synthesis (CFPS) systems and other synthetic biology approaches. The common finding is that all of these technologies can produce protein drugs, antibodies, and vaccines on demand.”
The increased availability of artificial intelligence and digital technology is another factor facilitating the move away for centralized production, points out Dai, who says enhanced process modeling and control will play an important part of on-demand manufacturing.
“We believe that advanced machine learning algorithms and AI-based tools, together with automation can play a key role in improving the efficiency of manufacturing, for example, such systems can be used to modulate the constitution of the CFP systems for increased output.”