28th May 2020: Pomezia, Italy – Advent Srl, an IRBM company and global leader in viral vector manufacturing, announces 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.
For Advent and the IRBM Group
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Advent, part of the IRBM Group, is a GMP-certified Contract Development and Manufacturing Organization, located in Pomezia (near Rome, Italy) within the IRBM campus. Advent is dedicated to the development and production of clinical lots of recombinant adenoviruses to support clinical trials for vaccine and gene therapy applications. Over the years, the Advent team has built an outstanding track record in the successful production of clinical lots for many infectious diseases, including ebola, and now coronavirus, and is committed to the highest GMP quality standard. For more information, please visit: www.advent-gmp.com.
IRBM is an innovative research organization working across all aspects of drug discovery and early development for different modalities – small molecule, peptides and antibodies. We foster collaborations with organizations from the pharmaceutical, biotech and academic sectors to accelerate drug discovery from target validation and hit identification to candidate nomination. Our 200 plus-strong, multidisciplinary team works at a state-of-the-art R&D facility near Rome where projects are carried out “under one roof” enabling rapid cycle times and close integration of the scientific teams. IRBM’s scientists have helped discover four drugs that are on the market and a further 25 compounds have gone into clinical testing. Now celebrating our 10th anniversary as an independent research organisation, we have laid the foundations to become a global centre for excellence in all aspects of drug discovery and early development. For more information, please visit: www.irbm.com.