europeanpharmaceuticalreviewJune 01, 2020
Tag: CDMO , COVID-19 vaccine , AZD1222
Advent, an Italian Contract Manufacturing Organization (CMO) has manufactured and delivered the first batch of ChAdOx1 nCoV-19 (now called AZD1222), a novel COVID-19 vaccine candidate, for Phase II/III clinical trial.
The COV002 trial is being undertaken by the University of Oxford, UK. The first batch included 4000 doses of the vaccine.
The AZD1222 vaccine uses a non-replicating adenovirus vector with the addition of the SARS-CoV-2 Spike (S) protein. SARS-CoV-2 is the virus causing the COVID-19 pandemic.
According to the CMO, it manufactured the first batch of vaccine in just over a month from receiving the seed stock. This was done by rapidly devising a manufacturing process to produce 13,000 doses of the COVID-19 vaccine. The company said the rapid and reliable development of a large-scale manufacturing process was critical, as Phase I trials are already underway.
“Speed is of the essence when facing a new outbreak such as this unprecedented Covid-19 pandemic,” said Professor Sarah Gilbert of the University of Oxford’s Jenner Institute. “Advent has manufactured and delivered the vaccine very quickly, producing a clinical batch in just over one month since we provided the seed stock, enabling us to rapidly prepare for larger scale clinical trials.”
The University of Oxford is partnering with AstraZeneca for the development and potential large-scale distribution of the vaccine candidate.
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