Ground Floor 10 St Andrew’s Place
East Melbourne, 3002
Australia
Phone: +61 (0)3 9656 5804
Fax: +61 (0)3 9656 1650
Description:
Cell Therapies Pty Ltd is a contract service provider supporting cell therapy clinical trials and commercial manufacture. A fully-integrated range of services covers all aspects of cell therapy trials, including production in compliance with Good Manufacturing Practices (cGMP), under FDA and (TGA) regulatory controls.
Services include:
• Protocol design and approvals
• SOP preparation
• Recruitment of investigators and patients
• Cell collection
• Process and analytical development, validation
• GMP manufacturing and QC testing (TGA-licensed facility)
• Cell therapy product administration
• Clinical interpretation and reporting
• Audit compliance
Based in the Peter MacCallum Cancer Centre and the Centre for Blood Cell Therapies, Cell Therapies can provide a one-stop shop for cell therapy clinical trials or commercial manufacturing. Our capacity to work with a wide range of cell types and clinical conditions has proven to be a powerful attraction for our clients. We can recruit patients from within our facility and/or in collaboration with other clinical sites, and can deliver reliable trial results under demanding protocol and reporting regimens.
Other resources at the Peter MacCallum Cancer Centre can be incorporated into clinical studies as well. A state of the art Diagnostic Imaging suite, for example, offers clinical and research PET, MRI, CT, SPECT, combined PET-CT, and Ultrasound imaging capabilities, and custom cell labelling, permitting in vivo tracking of administered cells over hours to days.