South Australia (SA)

Therapeutic Products Facility

 

SA Pathology, Royal Adelaide Hospital

Central Northern Adelaide Health Service

 


The Therapeutic Products Facility (TPF) was constructed in SA Pathology laboratories on the campus of the Royal Adelaide Hospital (RAH). It consists of a suite of 3 cleanrooms designed to enable the production under cGMP conditions of cellular therapies for clinical use. Two rooms are class 350 with the remaining room class 3500. It was qualified and commissioned in 2000.   The Therapeutic Products Facility aims to provide a facility where cellular based therapies can be manufactured to the highest standards of purity, integrity, safety and strength. Within the TPF there is a strong focus on product quality and safety at all times. The TPF provides physical and intellectual support clients in the manufacture of cellular based therapies of the highest quality by providing workspace, training, infrastructure, materiels and a quality system that complies with the applicable Code of Good Manufacturing Practice. The quality system within the TPF ensures product quality and incorporates elements required by the TGA, NATA, and ISO 9001:2008. The TPF and associated apheresis unit were the first to be licensed in Australia for the manufacture of allogeneic haemopoietic progenitor cells for transplantation(Licence number 73274). Haemopoietic progenitor cells are processed in the TPF in a Class II biosafety cabinet in a controlled environment with a dedicated HVAC system, HEPA filtration and positive air pressure meeting the requirements for a class 3500 cleanroom. The TPF is also licensed for the manufacture of autologous chondrocytes for implantation and for the manufacture of a completely autologous fibrin glue. As well the Burns Unit of the RAH utilises the TPF for the manufacture of autologous keratinocytes for the treatment of patients with major burns. They were the first manufacturer in Australia to be TGA licensed for the manufacture of autologous keratinocytes for implantation.  

Contacts  

Dr Ian Lewis                                                                                   
Medical Manager TPF                                                                                                                           
Ph +618 822 3022                                                                         
ian.lewis@health.sa.gov.au           

Mrs Pamela Dyson  
Scientific Manager TPF 
Ph +618 8222 3453                                                 
pamela.dyson@health.sa.gov.au