Cytotoxic and High-Potency Manufacturing
30+ years of dedicated cytotoxic manufacturing expertise. A purpose-built oncology facility. Regulatory credentials to supply the world's most demanding markets.
What Sets Us Apart
Dedicated Oncology Environment
A self-contained facility built specifically for cytotoxic programs, with its own laboratories, manufacturing environment, and quality systems from day one.
01
Containment Systems
Restricted Access Barrier System (RABS) filling restricts access to the critical filling zone, providing full operator and product protection.
02
Decades of Experience
A long-tenured specialist team with deep institutional expertise, built through decades of uninterrupted cytotoxic manufacturing.
03
Every Chemotherapy Classes
Commercial manufacturing experience across anthracyclines, platinum-based chemotherapies, taxanes, topoisomerase inhibitors, antimetabolites, and vinca alkaloids.
04
From First Batch to Commercial Supply
Feasibility and Technology Transfer
Compound-specific feasibility assessment and containment level review. Technology transfer with cleaning validation and containment verification.
Clinical to Commercial
Clinical-scale GMP batch manufacture under RABS containment through to commercial scale-up, stability management, and multi-SKU portfolio management for late-lifecycle programs.
Global Regulatory Alignment
CMC documentation and regulatory submission support for IND, CTN, NCE, and commercial applications. QC release and distribution to 70+ countries across FDA, EMA, TGA, and ANVISA markets.
View Technical Specifications
What We Can Handle
Containment Classification
RABS containment rated to OEB5, with an OEL below 1 µg/m³. Designed for cytotoxic, high-potency, and highly active compounds requiring the highest level of operator and product protection.
High-Potency Products Manufactured
Oncology classes manufactured include anthracyclines, platinum-based chemotherapies, taxanes, vinca alkaloids, antimetabolites, and topoisomerase inhibitors, across clinical and commercial programs.
Did you know manufacturing in Australia could fund nearly half your program?
Learn More
Drug Product Manufacturing Track Record
0+ years
of Sterile Manufacturing Heritage
0M+ units
Annual Capacity
0+
Approved Products
0+
Countries Delivered
Ready to Scale Your Oncology Program?
Our team is ready to discuss your cytotoxic manufacturing needs.