Lifeblood becomes Australia’s first licensed stool transplant manufacturer

Lifeblood becomes Australia’s first licensed stool transplant manufacturer

Australian Red Cross Lifeblood has become Australia’s first licensed faecal microbiota for transplant (FMT) manufacturer.

The Therapeutic Goods Administration (TGA) approved Lifeblood’s licence application to collect and manufacture FMT from its Perth-based processing facility earlier this week.

FMT is made by collecting a stool from a healthy donor, processing and testing it, then giving it to clinicians to transplant into a patient to relieve and treat debilitating, often, life-threatening disease.

New TGA standards that come into effect next month mean non-hospital FMT manufacturers must hold a TGA licence.

Lifeblood Executive Director Stuart Chesneau said Lifeblood was proud to be the first TGA-licensed FMT manufacturer in Australia.

“Lifeblood already has the expertise in supplying donated biological products from our blood and milk services, so becoming the first TGA-licensed FMT manufacturer has been a natural step to help us improve even more lives,” Mr Chesneau said.

“The new TGA licensing requirements are very important as they will ensure FMT products are safer for patients and consistently meet a high standard of quality.”

Australian Red Cross Lifeblood is also the only national not-for-profit manufacturer of FMT in Australia.

“At Lifeblood we’re always looking for more ways to help Australian patients through vital, life-giving biological products,” Mr Chesneau said.

“Being able to easily access safe FMT has been a major roadblock in treatment for patients, so this is a very important step in making treatment more accessible to Australians in need.

“As always, it’s thanks to the help of our wonderful volunteer donors that Lifeblood is able to produce a reliable supply of products to help save lives.”

Lifeblood is currently manufacturing Lifeblood FMT as part of a pilot program to provide Fiona Stanley Hospital with a supply for treatment for patients suffering from a serious infection known as recurrent or refractory Clostridioides difficile infection.

As part of the future pathway, Lifeblood will be seeking expressions of interest from clinicians across Australia to make FMT accessible to even more patients.

In the future, Lifeblood also plans to supply FMT for use in research programs to treat other conditions such as ulcerative colitis, Crohn’s disease, immunotherapy and major depressive disorders.

Lifeblood is funded by Australian governments to provide blood, blood products and services to the Australian Community. For Microbiome, Lifeblood has been grateful to receive contributions from HBF, the McCusker Charitable Foundation and Rotary WA. 

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