Case Studies

Manufacturing active pharmaceutical ingredients for clinical trials

IDT: The contact from IDT

Australia Successful pharmaceutical companies rely on new products to keep them ahead of the competition, but developing and bringing them to market on time and on budget requires knowledge, competence and a proven track record.

IDT helps fast-track products from research and development, through to clinical trials. With over 35 years’ experience, IDT has developed more than 115 products for customers including 9 of the top 10 pharmaceutical companies worldwide.

IDT specialise in developing and manufacturing complex, highly potent drugs, beta-lactam antibiotics and cytotoxic products at their Melbourne manufacturing campus. In addition, IDT CMAX is a 50-bed clinical trial unit currently located at the Royal Adelaide Hospital, South Australia.

IDT CMAX specialises in first-in-human studies, and has conducted over 75 to date. In 2016 IDT CMAX will relocate to purpose-built premises adjacent to the new South Australian Health and Biomedical Precinct. This will be the largest health precinct in the southern hemisphere, and provide the foundation for a cluster of organisations to deliver world-leading research and clinical service delivery. Centrally located, with easy access to public transport for study participants and customers, the new facility will continue to offer 50 beds, allowing flexibility for study scheduling and fast study startup times.

Most recently IDT helped a United States biotechnology company efficiently conduct a Phase I trial of their product. They chose IDT to conduct active pharmaceutical ingredient (API), finished dosage form, and early proof of concept clinical work. IDT helped to manufacture the API and formulate the drug product, which was then put into Phase I clinical trials at IDT CMAX. This biotechnology company was able to access the R&D tax incentive tax credit, and quickly start the trial process using the CTN scheme, without needing to secure a United States Investigational New Drug (IND) filing, saving both time and money.

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