The New South Wales (NSW) Organ and Tissue Donation Service (OTDS) also known as DonateLife NSW is part of the Australian Organ and Tissue Donation Network and is the state-wide donation agency responsible for saving and improving the lives of Australians through optimising every potential opportunity for organ and tissue donation for transplantation.

The OTDS has two business arms, Organ, and Tissue, responsible for the recovery of organs and tissues, as well as manufacture tissues to meet the demand for transplantation in NSW and the Australian Capital Territory (ACT). Organ has a budget of $12million p.a. while tissue is self-funding. The OTDS is the only combined organ and tissue donation agency in Australia, however, is physically located across two sites approximately 13km apart. Co-location of the service is desirable to recognise synergies, to improve integration and collaboration between the two business arms and to provide a hub for the education and training programs that are currently provided off site.  This would also represent an Australian exemplar of an integrated organ and tissue donation service.

Since mid-2020, an extensive search of over 50 properties has been carried out with only one location considered suitable. A non-binding commercial term or Heads of Agreement has been agreed, capital funds are being sourced and a lease is being negotiated.

The main driver for change was to expand and improve the Tissue Bank to meet increasing TGA GMP licensing requirements. The new facility will meet regulatory and workflow requirements for the production of current tissue grafts as well as be responsive to new supply and demand to meet patient and clinician needs created through research and emerging technologies. It will also be a catalyst for research and translational activities amongst universities and clinicians. The resource will train the next generation of donation medical and nursing specialists and scientists with the biofabrication skills relevant to clinical and biomedical industries of the future. The facility aims to remove the technical challenges faced when advancing innovative medical concepts to the prototype stage by providing state-of-art biofabrication equipment and world-class expertise to accelerate commercialisation. Currently there are no such facilities available in NSW and the lack of these facilities is causing a roadblock to development and deployment.

The completion date is yet to be determined pending authorisation of the lease. Building completion of the clean room core is prerequisite for the validation, TGA Inspection and license negotiations that are required before transitioning manufacturing functions. The validation and accreditation process will require a lead in period, and a period of dual operation between sites, approximately 6-12 months. 

The OTDS will be happy to share our experience and learnings in driving this innovation in Australia with other agencies both locally and internationally.