The services range from laboratory rental through to fully-integrated planning and execution of clinical trials that involve cellular therapeutics manufactured in code of Good Manufacturing Practice (cGMP) and Therapeutic Goods Administration (TGA) licensed facilities.

Our laboratory was the first in Australia to obtain TGA www.tga.gov.au approval for its operations (License #149827).

Cellular therapies (CT), cell-based therapies, tissue-based therapies, and tissue engineering encompass a broad, rapidly growing field of medicine that involves the manipulation and administration of cells for the treatment of disease.

This field can be categorized in various ways, based on

1. the starting cell population (e.g., embryonic stem cells, adult stem cells, islet cells),
2. the type of cells generated in the process (e.g., dendritic cells, chondrocytes),
3. the disease or organ targeted (e.g., cardiac disease, diabetes),
4. the type of manipulation (e.g., cell expansion, gene therapy) or,
5. the complexity of manipulation

Common features of all CT are requirements that source cells be identified, collected, processed, stored, transported, and administered.

Each step must incorporate procedures that ensure that the integrity of the end cellular product is maintained. Thus, one should approach the production of a CT no differently from the production of a pharmaceutical drug or medical device — including requirements that the entire process occur in appropriate physical environments with protocols and procedures linked to high-level quality systems. The manipulation of human cells to produce cellular therapeutic products is, with a few exceptions, still considered an experimental therapy.

In association with

Cell Therapies Pty Ltd ABN 100 285 916