Securing supply of critical pharmaceutical compounds
The pharmaceutical industry is undergoing a profound shift in how high-value active ingredients and vaccine components are produced. For decades, manufacturing has relied on resource-intensive, environmentally burdensome and globally fragmented supply chains. The limitations of this model have become increasingly visible. “The global push for sustainability – from regulators, international health organisations and society – is reshaping expectations,” explains AlkaBurst2.0(opens in new window) project coordinator Sarah-Meryll Buet from Alkion BioInnovations(opens in new window) in France. “The pharma sector is increasingly expected to reduce its environmental footprint and transition towards controlled, low-resource, carbon-efficient manufacturing systems. It is also important that European vaccine companies reduce their reliance on overseas production.”
Large-scale cultivation of plant biomass
French firm Alkion has developed new biorefinery technology to respond to these challenges. At the core of this innovation is AlkaBurst, a next-generation temporary immersion bioreactor platform, designed specifically for the fully controlled, large-scale cultivation of highly concentrated plant biomass. In particular, the company focused on manufacturing a potent vaccine adjuvant, traditionally derived from the bark of the soapbark tree, called QS-21. “Traditional plant-derived ingredients like QS-21 suffer from unpredictable yields, multi-year cultivation cycles, and highly variable raw materials,” says Buet. “Added to that, large-scale use can lead to deforestation.” The aim of Alkion’s solution is to enable the production of plant clones in closed environments, making it possible to standardise complex natural molecules and remove over-reliance on crops. “For critical ingredients like QS-21, this approach would help to strengthen the resilience of the global vaccine ecosystem, and remove a major bottleneck for future vaccine development,” adds Buet.
Robust, high-yield production of QS-21
The EU-funded AlkaBurst2.0 project sought to push this innovation forward by helping to transform Alkion’s lab-scale plant-bioproduction platform, including early QS-21 production and small-scale bioreactor work, into a pre-industrial pilot capable of supporting future manufacturing. This was achieved through a number of steps, including scaling up culture processes into robust industrial units, developing AI-assisted tools, and implementing advanced extraction and purification capabilities. Following implementation, the company was able to show that robust, high-yield production of QS-21 under controlled conditions was possible. The completed 40-litre industrial bioreactor platform was also shown to be more efficient, reliable and scalable than the company’s earlier 300-litre prototype. Automation was another major success. “We co-developed AI-assisted micropropagation robots that are now in the final integration stage,” says Buet. “These will allow the entire process to move towards true industrial automation.” Regulatory issues were also examined. “The project helped us to prepare the commercial pathway for bringing sustainable QS-21 to market,” adds Buet. “Overall, the project bridged the gap between laboratory innovation and real-world industrial deployment.”
Development of high-performance vaccines
These results have shown the potential of achieving sustainable, large-scale production of QS-21 in controlled conditions. “For the first time, pharmaceutical companies, biotech firms, universities and global health organisations will have access to secure, year-round supplies of this critical adjuvant,” notes Buet. This in turn will accelerate the development of high-performance vaccines against existing and emerging infectious diseases, strengthen biodefense preparedness, and support advances in immuno-oncology. The veterinary sector also stands to benefit, where more potent adjuvants are increasingly needed. “Beyond QS-21, this platform opens the door to the production of many other high-value ingredients where Europe faces strategic dependency,” remarks Buet. “This bioproduction technology is inherently versatile, and can be rapidly redeployed to produce additional adjuvants, rare bioactives and other critical compounds.”
