Dominic Wall and Miles Prince
Regulation of Cellular Therapies: the Australian Perspective .PDF Doc 82 Kb

"The first step in the process of regulating cell-based products was taken in 1991, when the code of good manufacturing practice (cGMP) for 'Blood and Blood Components' was instituted."
"The TGA will become the formal regulator of all cell-based therapies and laboratories will be required to apply for cGMP auditing and licensing. It is likely that the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines or others of a similar nature, will form the basis of one of the regulatory standards for HSC processing. Of particular note is the the inclusion of apheresis as an integral component of cGMP licensing.

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H. Miles Prince, Dominic P. Wall, Kerrie H. Stokes, Ray Wood,
Scott R. Burger, Patrick Coghlan and Neil Boyce
Cell processing for clinical trials and commercial manufacture .PDF Doc 472 Kb

"We elected to design and construct a facility that would remain as “generic“ as possible, to enable adaptation to potential future demands of CT. This design meets the technical and regulatory demands required to sustain cells in short- and long-term culture (process cleanroom) as well as meeting the sometimes conflicting requirements for gene transduction protocols (process cleanroom, containment). Because of our own long-term research objectives, we also incorporated more specialized equipment, such as a high-speed cell sorter for rare target cell isolation, within the cleanroom environment."