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Manufacturing a COVID-19 vaccine

Incremental progress over many years has been made in the research laboratory settings of the Jenner Institute, and importantly also in the optimisation of manufacturing practices at the CBF.  Research brings the new ideas, and manufacturing makes the new ideas viable as medicines for human diseases in the form of doses ready to be delivered to the clinic. Over the years, different viral backbones were employed, and different manufacturing processes were developed. The now well-known ChAdOx1 vector was developed by the researchers at the Jenner Institute in 2012.

In December 2019, a pneumonia-like disease was spreading through Wuhan, China. The sequence of the SARS-CoV-2 virus was made freely available by Chinese researchers, in the first of many international acts of collaboration seen throughout the pandemic. In January 2020, researchers at the Jenner Institute designed a string of DNA containing the sequence of the Spike protein of this new virus. How did they know to use the Spike protein as their target? From work performed a few years back on another coronavirus, MERS. The CBF was involved in the manufacture of the MERS vaccine, along with other ChAdOx1 vectors.

Thanks to the previous knowledge of how to design an effective vaccine to a coronavirus AND the experience of manufacturing a vaccine to the highest standards, the unique position of the Jenner Institute researchers and the qualified team at the Clinical BioManufacturing Facility allowed the teams to move at an extremely rapid pace.

Meanwhile, the Production Team were in the manufacturing cleanroom suites working on another vaccine at the time, but it quickly became evident in February that COVID-19 was becoming a concern worldwide and a decision was made in agreement with the Principal Investigator and the CBF Senior Management Committee to postpone the final part of the campaign and to move swiftly onto the ChAdOx1 nCoV-19 project. While on paper this seemed straight-forward, many simultaneous processes had to take place in order to make this happen, all in rapid time. In addition to the practical work being performed 7 days a week by the Starting Material, Quality Control, and Production Teams, many other aspects needed to be addressed in regards to risk assessments, documentation, and supply of materials, for which the Quality Assurance Team, Qualified Persons and IMP team also worked long evenings and weekends to ensure all processes were being completed as required by regulations. During this time, the Facilities Team were also making sure the building, labs, equipment and cleanrooms were all maintained to the highest standard. Storage space quickly became an issue but this was sorted thanks to the Operations Manager and Operations Assistant.