contractpharmaMay 29, 2020
Tag: IRBM , ChAdOx1 nCoV-19 , Advent , COVID-19
Advent Srl, an IRBM company, has manufactured 13,000 doses of the novel Covid-19 vaccine candidate, ChAdOx1 nCoV-19 (now known as AZD1222). The first 4,000 doses have been delivered for use in the Phase II/III clinical trial COV002 by the University of Oxford, England.
Following the partnership announced on February 7 between The Jenner Institute and IRBM’s Advent to manufacture ChAdOx1 nCoV-19, Advent has now manufactured its first batch of vaccine in just over one month from receiving the seed stock. Advent rapidly devised a manufacturing process incorporating high quality process development, and extensive quality control, to produce 13,000 doses of the vaccine for use in Phase II/III clinical trials. With Phase I trials already enrolled for this vaccine, rapid development of a large scale manufacturing process is a critical step in quickly and safely delivering the vaccine for further trials.
The vaccine comprises a non-replicating adenovirus vector with the addition of the SARS-CoV-2 spike protein of the COVID-19 virus. It is hoped that the vaccine will result in people forming antibodies to the COVID-19 spike proteins, which should prevent infection and generate immunity in the tested population. On April 30, the University of Oxford partnered with AstraZeneca for the development and potential large-scale distribution of COVID-19 vaccine candidate.
Professor Sarah Gilbert of the Jenner Institute said, “Speed is of the essence when facing a new outbreak such as this unprecedented Covid-19 pandemic. 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.”
Dr. Piero Di Lorenzo, President and CEO of ADVENT and IRBM said, “Our scientists have been working tirelessly, and with great passion, to manufacture and support the development of the COVID-19 vaccine for clinical trials. Rapid and reliable manufacturing of high quality batches of the vaccine for clinical trials will be a critical step in getting it approved for use in people in order to overcome this global pandemic.”
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