Melbourne drug development and manufacturing company IDT Australia has received extensions to its manufacturing licence from the Therapeutic Goods Administration effectively completing its program to bring the company’s sterile manufacturing facility into a state of readiness to manufacture Covid-19 mRNA technology vaccines.
The new approvals allow the company to manufacture sterile injection and sterile solution of dosage forms – until now it had been restricted to producing vial forms
IDT is to be paid $11.44 million by the federal Department of Health under a contract to make ready its sterile manufacturing facilities at Boronia in Melbourne
The contract provides for a period of exclusivity with Canberra lasting either four months or until a supply agreement is executed with the government to provide Covid-19 vaccine services.
Despite the payment, there is no obligation on Health to utilise ITD’s facilities.
Development of capabilities to manufacture a particular vaccine would require further approvals and technical transfer to the company.
This could come from an existing mRNA vaccine producer such as Moderna or Pfizer, or from a research organisation developing vaccines and vaccine components.
IDT has been in extended discussions with Monash University and the Victorian government regarding the university’s Monash Institute of Pharmaceutical Sciences mRNA receptor binding protein vaccine candidate.
Picture: IDT Australia/sterile manufacturing facility
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