Clinical Trials

Our Clinical Trials team offers patients the opportunity of access to novel cell and genetic therapies, often when little to no alternative therapeutic options may be available. Our aim is to allow people to live longer, healthier lives and reduce hospital visits by helping develop new treatments. Utilising the services of our integrated cell processing laboratory allows us the opportunity to collect, manage, store, prepare and dispense investigational cell and gene therapy products. In addition to running our own Clinical Trials we also support Pharmacy and other trials at RPA with specialised storage of fully traceable patient specific products.

Operations

Operations are conducted in accordance with international, national, local and facility guidelines and regulations to ensure world class cell processing and preparation of quality cell and gene products. Our apheresis and transplant service were the first in NSW to be licenced by the TGA. We are also familiar with both U.S. Food & Drug Administration and European Medicines Agency requirements including PIC/s.

Process Development

Cell manufacturing processes are taken from research protocol through to clinically relevant scale in a separate process development laboratory. Staff training, documented processes and material and equipment qualification ensure that the developed processes will enable the manufacture of safe and consistent products in the cGMP environment. Process Development Laboratory infrastructure is supported with funds from the National Collaborative Research Infrastructure Strategy and Therapeutic Innovation Australia.

Facilities

The self-contained, state of the art facility of over 400 m2 has been designed with flexibility to meet clinical research requirements. The manufacturing space includes four separate clean room suites, a large quality control and support laboratory, raw materials, and cell product storage facilities plus scientific and administrative support areas. The facility can accommodate the diverse needs of clinical academic researchers, as well as international biotechnology industry partners.

We have two large positive pressure, and two smaller negative pressure clean rooms to accommodate conventional and gene modification protocols. Isolated entry and exit gantries for each laboratory ensure unidirectional personnel flow. A central support laboratory provides common storage space and Quality Control testing facilities. All critical equipment used for product processing or storage is connected to a central environmental monitoring system that operates 24/7. Local visual alarms and remote alarms alert staff to ensure product quality and safety.

The facility was designed to be compliant with the Australian TGA standards for the manufacture of human cells for therapeutic use and the Office of the Gene Technology Regulator for clinical manufacturing protocols involving genetic modification. Revolutionary technologies using human cells and genetic engineering for the development of novel therapies could provide cures for many human diseases - heart disease, organ failure and some cancers, as well as genetic diseases such as haemophilia and thalassaemia.

Our Research Team

Rasko Lab

Understanding Disease – Finding a Cure

We are driven by the belief that the causes of disease must be understood at their molecular origins if rational treatments are to be designed. To understand cancer causation and the roots of genetic disease, we need to first understand how normal cells function.

Our primary goal is to integrate innovative cell and gene therapy research to improve human health. The Rasko Lab is comprised by the Gene & Stem Cell Therapy Program, the Li Ka Shing Cell & Gene Therapy Program, the Computational BioMedicine Lab and the Cancer & Gene Regulation Lab.

Selected Grants

Our Publications

Latest Publications

Requests for the use of Advanced Medicinal Products