IDT Australia will go ahead with manufacturing an mRNA vaccine developed by Monash University as the long awaited technology finally reaches Australian shores.
The basic technology behind the Pfizer and Moderna COVID-19 vaccines will be used by the Melbourne pharmaceutical manufacturer to make a vaccine candidate developed by the university’s Institute of Pharmaceutical Sciences (MIPS).
IDT will manufacture the “mRNA COVID-19 receptor binding domain” vaccine candidate for clinical trailing.
It will utilise its sterile manufacturing facilities, which were made ready and held available for the purpose under a contract with the federal department of health.
MIPS’ mRNA vaccine will be Australia’s first locally developed COVID-19 mRNA vaccine to advance to clinical trials – which are hurdles the vaccine still has to pass before being approved for use in the community.
IDT announced on Wednesday it had entered into a master service agreement with an accompanying services order to provide contract manufacturing services to MIPS. The contracts are worth $2 million.
The company had sought and received approval from the Department of Health to utilise its sterile manufacturing facilities to perform work for Monash.
The work will cover: “cGMP manufacturing services encompassing…technical transfer, vendor assurance, specialised equipment installation and commissioning, documentation, analytical method development, lipid nanoparticle formulation, engineering trials, cGMP batch manufacture and stability trials”.
Monash will supply the bulk raw materials including up to 200mg of mRNA drug substance encoding part of the SARS-CoV-2 spike protein, excipients, liquids and polymers.
“We are building an RNA ecosystem that will lead to the rapid development of life-saving vaccines and therapeutic treatments,” Monash University vice-chancellor Professor Margaret Gardner said. “…We need our own mRNA production connected to R&D, and late-stage clinical trials capability.”
IDT was to be paid $11.44 million by the federal government to make ready its sterile manufacturing facilities at Boronia in Melbourne, and was also given Therapeutic Goods Administration approval to utilise mRNA technology. The company also received Victorian Government support.
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