 |
|
Cell Therapies Pty Ltd have established a formal long-term collaboration with the Australian Red Cross Blood Service. This involves the joint appointments of a quality systems manager and a quality systems officer to control the centre's quality service along with a document control function provided through ARCBS.
The Centre for Blood Cell Therapy has worked collaboratively with the TGA and others including the Gene Manipulation Advisory Committee and the Gene Therapy Research Advisory Panel of the National Health and Medical Research Council to ensure current and on-going compliance with the evolving standards for cell and tissue based therapies.
Special laboratory features | 
Peter Mac's CBCT was the first cGMP and Therapeutic Goods Administration-accredited laboratory in Australia, (TGA License Number 149827). The TGA is a unit of the Federal Department of Health and Ageing and is responsible for administering the provisions of the Australian legislation for blood and related bio-materials. The TGA carries out a range of assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard. The TGA Website www.tga.gov.au has a detailed background and details of the regulatory environment.
Our regulator has specified that apheresis is to be an integral part of the regulated manufacturing environment. The apheresis at Peter Mac comes under the direct control of the CBCT, and, we are putting in place arrangements for remote site apheresis collection and transfusion
Cell Therapies Pty Ltd. provides clients and collaborators with a fully-accredited, focused business unit, operating under strict codes of practice, that is able to negotiate and to execute all aspects of contract engagements. We are able to provide access to the hospital’s wider expertise in advanced imaging, clinical trial design and approval, recruitment of principal investigators and patients, licensed manufacture, audit compliance, clinical interpretation, and reporting. We build on our experience in protocol development and SOP preparation, while matching research imperatives to licensed production restraints.
