It was a lunch break with a difference when interested AGW delegates and a curious medical journalist were bussed from the Adelaide Convention Centre for a quick tour of the new BiomeBank facilities.
Co-founder Dr Sam Costello told the visitors that an early iteration of Australia’s first public stool bank was initially established at the CSIRO in 2013, moved to the Basil Hertzel Institute in 2016 and became BiomeBank in 2017.
It has recently found its home in Adelaide’s inner west suburb of Thebarton.
BiomeBank has been supplying SA Health with product since last year to treat over 100 patients with C. difficle infections. It is also involved in clinical trials of FMT for ulcerative colitis.
His colleague and co-founder Dr Rob Bryant told the limbic the laboratory set-up in the compact facility was almost complete.
“What we are trying to do is focus on the safety and focus on good manufacturing practice to make sure our lab is GMP-certified according to TGA specifications,” he said.
He said they had a collaborative working arrangement with the TGA, which was still grappling with regulatory issues surrounding faecal transplants.
“Part of it is the difficulty with standardising the product. Because of its nature, it’s very difficult to say there is a standard FMT.”
Dr Bryant said there was a clinical need for FMT products given the increasing prevalence of potentially life threatening C. difficile infections.
“As it stands across health jurisdictions there is inequitable access to FMT and by that we mean, in some settings where FMT is clinically indicated as per guidelines, people are turning to relatives or even other sources of stool for FMT which is an ethical compromise and also potentially a safety compromise. It’s not best practice,” he said.
The screening tests done on blood and stool specimens were exhaustive, he added, and as a consequence FMT could not be provided in acute situations of clinical need.
“It needs to be done in advance. A frozen stool bank certainly makes sense and if we have the national capacity to distribute and the logistics therein, we can provide equitable access and that is our mission.”
“Although the laboratory is small, we are confident in our capacity to distribute and meet national demand. If you look at comparable facilities, the OpenBiome stool bank is of very modest physical size and yet is able to supply the entire USA.”
FMT products will come in several forms including stool aliquots for colonoscopic delivery and stool aliquots for enema delivery. BiomeBank was also currently working on capsules for oral ingestion.
“We hope to continue to work with healthcare providers and more systems based health networks to be able to distribute FMT for approved clinical indications.”
“We’re also willing to partner in clinical trials and play a role in the rational design of microbial therapies.”