The biomanufacturing program aims to address sector-wide regenerative therapy manufacturing challenges to develop a cost-efficient pipeline to bring new therapies to market for the benefit of Australian communities.
The program encompasses cell and cell-based therapies and aims to address wide-ranging industry bottlenecks in process development, bioprocess manufacturing, cryopreservation and scale-up of regenerative therapies, diagnostics, and quality assays and metrics.
Indicative outcomes include:
- Access to high-value cells, tissues and banks from screened donors
- Customised process development for cell-based therapies at scale to support commercial manufacturing
- Detailed quality management systems to facilitate regulatory acceptance
- Mechanism of action studies that underpin clinical efficacy and end use applications
- Potency and identity assays to ensure batch and product consistency
- Safety and efficacy testing to accelerate clinical translation
KEY PERSONNEL
Dr Heather Donaghy
Biomanufacturing Co-Lead
Therapeutic Innovation Australia
Prof. Simon Barry
Biomanufacturing Co-Lead
University of Adelaide