![]() Oxford/AstraZeneca, Valneva, Novavax and CureVac are all producing COVID-19 vaccines in the U.K. Finally, manufacturers have increasingly focused on local supply chains because the pandemic threatened global trade. Pharma companies and CDMOs have also directly invested in additional capabilities, such as Pfizer’s purchase of seven lipid manufacturing machines from Polymum Scientific at a cost of c. $10 billion funding from governments and other sources - such as Operation Warp Speed in the US and the global Coalition for Epidemic Preparedness - has in part been invested in capacity expansion. To overcome material and equipment shortages, stakeholders with existing capabilities have diverted production capacity toward COVID-19 vaccines, temporarily using existing production lines whilst building new capacity. As with all innovative approaches, the supporting industry, such as contract development manufacturing organisations (CDMOs, lipid nanoparticle producers) is still nascent and required time to ramp up production to meet demand. For example, Pfizer invested $2 billion in late 2020 to build its own cold-chain network. The ultra-low-temperature storage of mRNA-based vaccines posed a particular challenge to rapid manufacturing and distribution on this scale, necessitating significant investment. Innovative vaccines − such as viral vector- and mRNA-based vaccines − had never been manufactured at scale before the pandemic, hence optimised processes and expertise were lacking. Whilst processes to manufacture traditional modalities − such as live-attenuated or inactivated virus vaccines − are well established, these require time to scale up. Each technology comes with its own specific challenges. ![]() Manufacturing process complexity arises from the need for rapid production and the prompt resolution of technical issues. ![]() There have also been challenges in sourcing sufficient reagents, such as enzymes and lipids for mRNA- and DNA-based vaccines, and cell culture media for other vaccine technologies. Shortages of materials and components - such as natural rubber, vials, syringes, flow filters and cobalt-60 for irradiation sterilisation - have all been reported. Material and equipment shortages impact a range of steps in the production process, including active pharmaceutical ingredient (API) or vector manufacturing, fill-and-finish services, and even testing and quality control. ![]()
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