As VivaZome moves towards IND-enabling studies and clinical trials, the VivaZome Science Team is addressing quality and regulatory requirements as evidenced by a QTTP poster presented by VivaZome scientists, Dr. Ella Johnston and Nicole Wasco, at the recent ANZSEV 2025 conference.

Their poster entitled “Quality Target Product Profile (QTPP): Towards commercialising therapeutic extracellular vesicles” highlighted that VivaZome’s manufacturing technology is underpinned by a quality control framework to enable clinical translation. Regulatory authorities (FDA, EMA, TGA) require documentation to support drug development, with key documents including the Target Product Profile (TPP) and the Quality Target Product Profile (QTPP).

Focusing on the QTPP, Ella and Nicole highlighted that well-defined Critical Quality Attributes (CQAs) ensure that the EV product has reproducible product quality and functional properties across a robust manufacturing process.

Ella and Nicole wrapped up by stating “This work demonstrates the critical interplay between advanced EV manufacturing, rigorous quality frameworks, and regulatory alignment. By establishing a well-defined QTPP and characterising VZT-PEVs across key critical quality attributes (CQAs), we have established a strong foundation for the clinical translation of VivaZome’s EV-based therapeutics.”

To view poster, click here

VivaZome’s work to optimize and scale its EV manufacturing process was on display at the recent ANZSEV conference in Wellington, New Zealand.

VivaZome’s Head of Manufacturing, Johannes Weber, presented “Clarification of cell culture supernatant in a scalable EV manufacturing process” both as a poster and a presentation.

Johannes highlighted that filtration is an essential step in EV manufacturing, but initial clarification and guard filtration prior to chromatography can result in significant particle loss.

To address this, Johannes and his colleagues conducted filtration studies and assessed commercial anti-fouling agents with an emphasis on EV recovery, scale-ability, and GMP compliance.  The outcome was an optimised protocol and filter configuration that efficiently removes contaminants and delivers an excellent EV recovery of 95%.

To see the poster, click here

At the 2025 annual conference of ANZSEV – the Australian and New Zealand Society of Extracellular Vesicles – VivaZome’s Senior Translational Scientist, Dr Smriti Krishna, presented “Extracellular vesicles improve functional outcomes after moderate traumatic brain injury (TBI) in a preclinical model”.

Dr Krishna presented data demonstrating that in preclinical studies at the University of Queensland, VivaZome’s EVs improved motor function 24 hrs post-TBI, while, in the epilepsy arm, animals treated with VivaZome’s EVs exhibited a trend toward reduced seizure frequency and increased latency to generalized seizures. These proof-of-concept findings highlight VivaZome EVs as a promising treatment for brain injury.  Mechanistically, VivaZome’s EVs are enriched in miRNAs with known anti-inflammatory potential which may help modulate the neuroinflammatory pathways and support recovery.

Clinically, TBI triggers uncontrolled, severe inflammation which disrupts brain repair and causes further brain damage leaving 10-15% of survivors with post-traumatic epilepsy. Dr Krishna highlighted that, every year, >300,000 Australians and 2.5 million Americans suffer a brain injury, which represents a substantial economic burden on healthcare systems.

To read the abstract of Dr Krishna’s talk, click here

This week in Melbourne, VivaZome’s Senior Scientist Johannes Weber presented a poster entitled “Process Development for Scalable Extracellular Vesicle (EV) Manufacturing” at the 18th Annual Bioprocessing Network Conference.

The poster – authored by Johannes Weber, Ella Johnston, Smriti Krishna, Nicole Wasco, Craig Newton, Xenia Sango, Louise White and David Haylock – highlights the challenges and key considerations in realising a scalable EV manufacturing. In response, VivaZome has developed a robust, reproducible, and scalable EV isolation process: “Our platform ensures consistent EV quality, maintains functional properties, and supports the transition from research-scale to clinical-grade manufacturing”.

With 350 attendees, the annual BioProcessing Network conference gathers together researchers, manufacturers, suppliers and others with an active interest in bioprocessing as applied to a broad range of industrial and academic research areas.

To view the poster, click HERE

VivaZome Therapeutics is delighted to announce that extracellular vesicles (EVs) from its proprietary human cell line have shown promising results in animal models of Traumatic Brain Injury (TBI). These encouraging findings were presented by VivaZome’s Chief Scientific Officer, Professor David Haylock, at the 2025 conference of the International Society of Extracellular Vesicles (ISEV) recently held in Vienna, Austria. The studies were conducted by our expert collaborators at the Centre for Advanced Imaging, Australian Institute for Bioengineering and Nanotechnology at University of Queensland (UQ), who have deep expertise in models of brain injury.

The full media release is available here.

The VivaZome poster “VivaZome Proprietary Human Cell-Derived Extracellular Vesicles Enhance Recovery After Moderate Traumatic Brain Injury in a Preclinical Model” is available here.