Virax opens new manufacturing unit

Virax Holdings has opened a new Vector Construction Unit (VCU) located in the School of Biomedical Sciences at Monash University.

The facility will be used for the construction of Virax's recombinant fowl pox vectors designed using the company's Co-X-Gene technology to deliver viral genes in combination with cytokine genes to boost the immune response to viruses including HIV and Hepatitis B, as well as cancer and other diseases.

CEO Dr David Beames said in a statement that the new facility would complement the existing GMP manufacturing facility, which is located at the Institute of Drug Technology in the Melbourne suburb of Boronia.

Previously, the company had outsourced construction of its vectors, said business development manager Dr Larry Ward, but the growth of the company made it more desirable to bring the process in house.

While the facility itself is not subject to regulatory oversight, it will allow the company to construct vectors under conditions consistent with GLP, he said.

Traceability of the process from the start, including all raw materials used, was important for gaining regulatory approval once GMP manufacture was in place.

Dr Paul Howley, who joined the company mid-year, will manage the new VCU. Ward said that Howley not only had experience in designing and constructing recombinant poxviruses, but also had the requisite commercial experience in GMP and regulatory issues necessary for a smooth transition into GMP manufacturing.

The facility is located in the Department of Physiology at Monash University, which is part of the Monash STRIP biomedical cluster. The laboratory was recently refurbished as part of the Victorian State Governments Science Technology And Innovation (STI) Initiative.

According to Ward, the company would have further opportunities in the future to expand into the STRIP building currently under construction on the campus, perhaps even consolidating the company in the precinct at a later date.