Why do CDMO’s in Europe, Asia and the US look to Australia for early stage clinical trials?
Manufacturing a cell and gene therapy (CGT) asset for clinical trials in Australia offers several compelling advantages, particularly for early-stage biotech companies or international sponsors looking to accelerate development:
- Regulatory Advantages
Australia’s Clinical Trial Notification (CTN) scheme allows sponsors to initiate clinical trials more quickly, typically within weeks, since it doesn’t require prior approval from the TGA (Therapeutic Goods Administration).
- Quality
Australia is home to specialized CGT CDMOs, particularly in Melbourne and Sydney, that provide GMP-compliant, Phase 1/2-ready capabilities, including:
-iPSC, CAR-T, TIL, NK cell, and MSC manufacturing
-Viral vector production (e.g., AAV, lentivirus)
- Access to Key Opinion Leaders and Clinical Sites
Australia’s world-class healthcare and trial infrastructure, with many facilities co-located with hospitals or research institutes, enables close integration between manufacturing and clinical sites.
- Ethnic Diversity
Populations across major cities are ethnically diverse, which enhances data generalizability, and have lower previous exposure to CGT trials which ensures cleaner datasets.
- R&D Tax Incentive
Offers up to 43.5% cashback on eligible R&D expenditures for companies with turnover <$20M AUD. This includes manufacturing costs, making Australia significantly more cost-effective than the US or EU for early-phase clinical work.
- Expert Workforce
High-quality academic hospitals and experienced investigators, and fewer competing trials compared to the US or EU, helping with faster recruitment.
Media Contacts
Cell Therapies Pty Ltd
Name: Dr Shrinidh Joshi, Head of Commercial Business Development
Email: [email protected]
Phone: +61 3 9492 4777
For further information please contact [email protected]
