IRBM’s Advent Manufactures 13,000 Doses of COVID-19 Vaccine for Use in Phase 2/3 Clinical Trials
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Advent Srl, an IRBM company and viral vector manufacturer, has announced it 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 2/3 clinical trial COV002 by the University of Oxford, England.
Following a long history of partnership, including the announcement on 7 February of an agreement 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, whilst ensuring high standards of quality control. Over the past decade, Advent has manufactured hundreds of thousands of doses of vaccine for over 10 different infectious diseases. The company has achieved a 100% success rate for the approval of clinical grade quality batches by regulatory authorities.
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 2/3 clinical trials. With Phase I trials already enrolled for this vaccine, rapid and reliable development of a large scale manufacturing process is a critical step in quickly and safely delivering the vaccine for further trials.
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.”
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 30th April, the University of Oxford announced a landmark partnership with AstraZeneca for the development and potential large-scale distribution of COVID-19 vaccine candidate.