Peter Mac’s excellence in cell and tissue manufacture led to the commercialisation and expansion of this business – Cell Therapies – as a manufacturer of cellular therapeutics.
In the VCCC building, Cell Therapies now operates the leading facility of its kind in Australia and the Asia-Pacific region.
Recent breakthroughs in gene therapy, immunotherapy, stem cell therapy and tissue regeneration have made Cell Therapies an internationally important business. It ensures that new therapies developed overseas can reach Australian patients and that cellular therapies developed by breakthrough Australian research can be produced to GMP grade quality and reach global markets.
Cell Therapies manufactures human cells as therapeutic agents. There are two broad categories of product:
- Autologous: using the patient’s own cells, manipulated and returned to them.
- Allogeneic: using a donor’s cells, banked, manipulated and distributed to (potentially) many patients.
Cell Therapies and Peter Mac
Cell Therapies is of strategic importance to Peter Mac because the business links our in-house research and development in gene therapy and immunotherapy – now heralded as the fourth pillar of cancer therapy – to patient care.
An on-site, integrated cell processing capability is rapidly becoming essential for leading global cancer hospitals such as Peter Mac.
In addition to research and laboratory exchange between Peter Mac and Cell Therapies, their co-location enables Peter Mac and Cell Therapies to run early-stage clinical trials and ultimately to provide access to the latest targeted therapies for our patients.
A prime example is "adoptive immunotherapy" with chimaeric antigen receptor T (CAR-T) cells, which provides patients with tailored immune killer cells against their own cancer. Cells are harvested from a patient’s blood, modified in the test tube in a clean laboratory environment for several days to "teach" the cells to powerfully kill cancer cells, then re-infused back into the same patient.
Cell Therapies and Peter Mac have recently partnered in a first-in-human study of CAR-T cells targeting the Lewis Y antigen (a specific receptor appearing in certain cancers) for refractory acute myeloid leukemia (AML). A clinical trial of CAR-T cells directed at Lewis Y in patients with Lewis Y-expressing solid tumours, including lung cancer, will commence in 2016.
Cell Therapies offerings
Cell Therapies offers contract manufacture of cells and tissues for clinical use; distribution of cell and tissue products in partnership with specialised sales and marketing partners; and consulting and advisory services for cGMP and regulatory compliance.
As a fee-for-service contract manufacturer, Cell Therapies’ services range from translating research findings into the clinic for first-in-man trials to full service support for standard of care therapies. Our services typically involve a consulting element, where we can provide local and international regulatory compliance advice and planning.
- Cell Therapies delivers flexible solutions across the full spectrum of cell and tissue manipulation.
- Cell Therapies can assist with the planning and manufacturing for clinical trials that involve the collection, manipulation and storage of cells and human tissue.
Cell Therapies is a private company, with Peter Mac being the majority shareholder.
Cell Therapies offers:
- Proven leadership and wide experience in cGMP cell manufacturing and regulation since 2003, and staff with deep and broad technical and regulatory expertise.
- Robust quality systems and enviable quality track record – this de-risks product transfers.
- Complete process development and deployment service – full “needle-to-needle” process control and deep clinical integration.
- Experienced in international regulatory and technology transfer to and from the US and EU – global compliance, consistency.
- Rapid, efficient trial start-up and commercialisation pathways.
- The ability to offer a single gateway to and from Asia, including Japan – a one-stop solution with flexible business models.
Dr Dominic Wall
PhD FFSc (RCPA)
Acting CEO and CSO
Email: [email protected]
Phone: (03) 8559 8419
Mobile: 0417 031 356