TGA inspection of StemSmart™ manufacturing completed
Miro Sciences (ASX: MSX) has announced that the Therapeutic Goods Administration (TGA) has completed its inspection of Q-Gen Cell Therapeutics (Q-Gen), the manufacturing partner for its StemSmart™ product.
The company describes the completed TGA inspection as a major operational milestone for the supply of StemSmart™ for future clinical trials.
It also calls the inspection an important part of the broader regulatory activities associated with supply of StemSmart™ for the planned Phase 2 clinical trial in refractory Crohn’s disease in Australia and the US, subject to regulatory approvals. MSX is targeting trial initiation by the end of CY2026.
Milestones building toward the Phase 2 trial
The inspection is the latest in a run of steps the company has reported as it progresses towards starting the Phase 2 trial:
- 1 October 2026: Southern Star Research appointed as clinical research organisation for the Phase 2 trial
- 13 October 2026: positive feedback from the Pre-Investigational New Drug (Pre-IND) submission meeting with the FDA
- 12 November 2026: TGA inspection of Q-Gen completed
The company says these achievements demonstrate continued and steady progress across its manufacturing, regulatory and clinical operations.
Dr Marian Sturm, Chief Scientific Officer and inventor of the StemSmart™ technology
“The TGA inspection of StemSmart™ manufacturing at Q-Gen demonstrates that we are on target with our technology transfer and represents an important step towards TGA licensure of our MSC product…”
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Why manufacturing readiness matters: the TGA audit explained
The TGA performs audit inspections of manufacturing procedures and facilities. The aim is to ensure compliance with established regulatory standards applicable for clinical trial supply of therapeutic goods for Australian patients.
According to the company, the TGA audit of Q-Gen is one of the critical steps in the manufacturing transfer of StemSmart™ to Q-Gen. That transfer is intended to scale up supply of clinical product for the planned Phase 2 trial in Australia and the US.
A clinical trial needs a dependable supply of product made to the required standards, which is why manufacturing steps sit alongside the regulatory and clinical workstreams.
Q-Gen at a glance
The company describes its manufacturing partner as follows:
- Located within QIMR Berghofer in Brisbane
- One of the largest cell therapy contract manufacturers in Australia
- 13 cleanrooms dedicated to cell manufacturing and quality control
- Holds a TGA licence for cell therapy manufacture
- More than 25 years in cell therapy manufacturing for industry
MSX says Q-Gen has the experience, expertise and capacity to manufacture StemSmart™ to meet MSX’s commercialisation goals.
StemSmart™ and the Crohn’s disease opportunity
StemSmart™ is a patented stem cell technology platform. The product is derived from adult human donor bone marrow-sourced mesenchymal stem cells (MSCs) developed at the Royal Perth Hospital in Western Australia.
It is produced using a patented manufacturing process that has been designed to improve therapeutic activity and clinical response. The process is also designed to modulate pathological immune responses that are often associated with severe and chronic inflammatory conditions.
The platform targets immune-mediated severe inflammatory diseases with a large treatment-resistant population. Refractory Crohn’s disease is the target of MSX’s initial clinical trial.
According to the company, early indications from a previous Phase 2 trial in refractory Crohn’s disease suggest StemSmart™ MSCs are potent, efficacious and safe.
What happens next for Miro Sciences
- Initiation of the Phase 2 clinical trial in refractory Crohn’s disease in Australia and the US, targeted by the end of CY2026 and subject to regulatory approvals.
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