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