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South Australian mRNA vaccines?

July 5, 2021

Published in Cosmos Magazine

Excerpts copied below. Read the full article in Cosmos Magazine at the link at the bottom of the page.

“Last month, the federal government closed applications for a critical approach to market process: it was looking for biotech firms that want to make messenger RNA (mRNA) vaccines in Australia. The successful bidder is likely to be announced by the end of August.

One of the bids was entered by BioCina, which – if the bid is successful – would produce mRNA vaccines at a facility in Thebarton, just west of the Adelaide city centre. BioCina bought the facility from Pfizer in August 2020. It had originally come out of the University of Adelaide in the 1980s; Pfizer had been operating it since 2015.

‘The plant was developing filgrastim, or pegylated filgrastim,’ says Ian Wisenberg, CEO of BioCina. Pegfilgrastim is used as a therapeutic following chemotherapy.

‘Pfizer made the decision to transfer that program to Europe, to their facility in Croatia, in Zagreb, and divest the facility, he adds.

‘That’s why we ended up buying [it], and we’ll take over the full operation by September 30th.’”

“The Thebarton facility, according to both Wisenberg and Anton Middelberg, professor of chemical and biomolecular engineering at Adelaide University, is the front-running bacterial cell plant in the country, and the only one with the right skillset and regulations already in place.

‘When you look at mRNA vaccines, you actually need to have capacity to make bacterial fermentation work and do that in a regulated facility, and the only regulated facility in Australia at the moment, for bacterial fermentation, is BioCina,’ says Middelberg.”

“Clinical safety is one of the strong points of the BioCina bid. The BioCina facility is the only bacterial cell-based plant in Australia that meets regulatory guidelines for therapeutic products.

The other complication is scale. There are a raft of engineering difficulties associated with making large amounts of mRNA and coating it with lipids.

‘Gee, that 2000 litre reactor with process control and computers hanging off it doesn’t look much like a test tube,’ jokes Middelberg.

BioCina’s bid involved a reconfiguration of the facility, to install technology that could easily produce mRNA vaccines.

‘BioCina has the workforce, it has a regulated facility,’ says Middelberg. ‘It needs cash to install some additional infrastructure, and then do the tech transfer from overseas to make COVID vaccines.’”

“If the bid is successful, BioCina could be producing mRNA vaccines within 12 months.

‘The strength of the proposal that we put forth is end-to-end solution with the key factor – which is the lipid nanoparticle technology encapsulation that’s required to deliver the mRNA,’ says Wisenberg.

Wisenberg says they’ve partnered with a firm that ensures BioCina will have the intellectual property rights to a lipid nanoparticle coating, greatly simplifying that part of the manufacture.”

“The plant will need to employ more experienced and early-career people with biotechnology backgrounds – particularly focussing on the engineering pathways for plasmid DNA, which is the first step in making mRNA.

‘We’re going to need to add people on the ground in the next 12 to 18 months,’ says Wisenberg. ‘And I’m hoping that we can draw from local talent.’ He adds that BioCina will be setting up an internship program.

Whether or not the facility will be useful in the current COVID crisis, both Middelberg and Wisenberg say mRNA is a sensible thing to invest in for the future. It has applications far beyond protection from coronavirus.

‘At the moment that whole field is opening up,’ says Middelberg.”