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TECHNOLOGY AND INNOVATION


says Christian Oliver Kappe, a chemistry professor at the University of Graz in Austria. There are increased efforts in the US and Europe to return the active pharmaceutical ingredient (API) manufacturing and the production of raw materials and intermediates back to those countries, says Kappe. In early 2021, US president Joe Biden signed


an executive order aimed at building US supply chains for critical materials and increasing their resilience. As part of the order, a report,  the need to invest in the development of new pharmaceutical manufacturing processes, and singles out continuous manufacturing. According to David Thompson, PhD, co-founder of Continuity Pharma, a US-based company that develops equipment used for this manufacturing method to produce essential medicines, the pandemic has likely increased the focus on continuous manufacturing.   Continuity Pharma a $1.5m grant to further develop its technology.


Continuous manufacturing takes off While the pandemic increased the attention on continuous manufacturing, we could have seen growth in the technology without one,  biomolecular engineering professor at New York University, says the industry was taking  Back in 2014, Amgen opened a $200m manufacturing plant in Singapore that included elements of continuous manufacturing. A year   US Food and Drug Administration (FDA)- approved drug manufactured using continuous flow protocols, and the company continued to use similar manufacturing processes for its other CF drug, Symdeko, in 2018. More    process to manufacture lipid nanoparticles. According to the WEF report, companies such as Eli Lilly, Johnson & Johnson, and Novartis are also making their forays into continuous manufacturing.


“While the pandemic increased the attention on continuous manufacturing, we could have seen growth in the technology without one”


Separately, Brexit has served as a key factor in the potential use of CFM in strengthening the domestic supply chain in the UK, says Ian Baxendale, professor, and director of impact at the Department of Chemistry at Durham University. In that sense, COVID-19 has not been the sole reason for an interest in CFM, but has rather given an opportunity for greater planning, he adds.  in securing API intermediates and the desire to do so domestically. The much-needed production of intermediates is often located  assembly, says Salvatore Mascia, CEO of Continuus Pharmaceuticals, a Boston-based company specialised in integrated continuous manufacturing. But all of those steps could be integrated into a single end-to-end solution with CFM, says Mascia. In January 2021, the US Department of Defense awarded $69.3m  domestic production capabilities. Elsewhere in the world, Baxendale and


Kappe point to increased interest in CFM in Africa and South America. Countries such as Brazil or South Africa could essentially skip a generation of processes and focus on developing a more continuous local API supply chain, Kappe says.  of CFM equipment in China and India. In December 2021, Shanghai Pharmaceuticals and Syntegon announced a partnership to build a CFM laboratory in China. This February, Asymchem Laboratories, a Chinese contract and development manufacturing organisation (CDMO), acquired Snapdragon Chemistry, a chemical technology company developing CFM


Clinical Trial Supply Handbook | 27


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