Monash University announces manufacturing agreement with IDT to produce mRNA COVID vaccine for clinical trials

14 October 2021

Monash University has entered an agreement with Melbourne-based biotech company IDT to produce drug product for the COVID-19 mRNA vaccine candidate being developed by the Monash Institute for Pharmaceutical Sciences (MIPS) for clinical trial.

If successful, the vaccine will be the first Australian mRNA vaccine manufactured in a current Good Manufacturing Process (cGMP) facility.

IDT advised the Australian Stock Exchange on 13 October it had signed a Master Service Agreement and Services Order with Monash that will see the company provide cGMP sterile contract manufacturing services to produce a drug product for MIPS’ mRNA COVID-19 receptor binding domain vaccine clinical trial.

The MIPS COVID-19 receptor binding domain vaccine project is funded by mRNA Victoria and the Commonwealth Government’s Medical Research Future Fund and the trials are expected to start by the end of 2021.

The receptor-binding domain mRNA vaccine candidate has been developed by MIPS in conjunction with The Peter Doherty Institute for Infection and Immunity and is Australia’s first locally developed COVID-19 mRNA vaccine candidate to progress to clinical trial.

Monash University President and Vice-Chancellor Professor Margaret Gardner AC said Monash is home to Australia's largest network of RNA and mRNA researchers.

“We are building an RNA ecosystem that will lead to the rapid development of life-saving vaccines and therapeutic treatments for communities across the country,” Professor Gardner said.

“To enable Australia to avoid ongoing issues around vaccine supply chains from other countries, we need our own mRNA production connected to research and development, and late-stage clinical trials capability.

“This partnership agreement with IDT and the ongoing support from the Victorian and Commonwealth Governments is a significant step in Australia moving towards establishing unlimited capability."

“We are very appreciative of the Australian Government’s support in getting IDT’s sterile manufacturing facility ready to take on a project of this nature; and for allowing IDT to utilise the facility for this work,” said IDT Australia Limited’s CEO, Dr David Sparling.

“We are also very appreciative of the Victorian Government’s support for this project. Being Australia’s first locally developed mRNA COVID-19 vaccine, all of the team here at IDT are excited to be a part of the MIPS project. It is a great opportunity for IDT to develop and showcase our cGMP manufacturing capabilities in mRNA product manufacture.”