Cell and Tissue Therapies WA (CTTWA)
RPH manufactures a range of cell and tissue-derived products for clinical therapeutic applications and distributes these locally and nationally.
The products include serum eye-drops, mononuclear cells, granulocytes, haemopoietic progenitor cell grafts (HPCs) from bone marrow, whole blood, mesenchymal stromal cells (MSCs) and apheresis collects.
This work is done in the Ray and Bill Dobney Cell and Tissue Therapies WA (CTTWA) facility which was built and commissioned in 2006 following a generous bequest from the Dobney family.
CTTWA also receives, distributes and delivers cell therapies manufactured elsewhere for clinical use by WA patients. Examples include adenovirus-specific T-cells, and genetically modified products to correct inherited metabolic disorders.
It is truly a clinical service facility and advanced therapies manufacturing centre of excellence.
CTTWA is Western Australia's only public TGA-licensed manufacturer of clinical grade cellular therapies.
Core Capabilities
- Australian code of current Good Manufacturing Practice (cGMP) compliant
- TGA licensed manufacturer, FACT-JACIE and NATA accredited
- Clinical service delivery and clinical program management with expert quality management personnel and extensive accredited clinical and laboratory quality management systems
- Clinical therapeutic product manufacturing facilities and services available for academic partners and commercial third-party clients
- Receives, stores, distributes and prepares cell and gene therapy products for patient delivery
- R&D capability assists research translation to GMP compliant, TGA accredited products through clinical trials
- Sponsors, supports and provides consultancy for clinical trials
- Part of the Australian NCRIS Network and one of the five national TIA Cell & Gene Therapy Capability facilities
Facilities
- ISO Class 7 cleanrooms, (four positive and one negative pressure) and critical laboratory infrastructure
- Cell processing equipment Sepax, CliniMACS Cell factories and bioreactors Terumo Quantum, Cytiva Xuri, G-Rex
- Cryopreservation and cryo-storage facilities
- Quality Control and Assurance including process control and product release testing
- Integrated building management system
- Electronic Quality Management System
- CRISPR capable non-viral genetic modification manufacturing platform
- AAV handling for in vivo gene therapy
Licenses, Standards and Accreditations
- TGA licensed to manufacture therapeutic goods (MI-25112004-LI-000212-1)
- FACT-JACIE accredited: cellular therapy product processing for minimal and more than minimal manipulation since 2014
- NATA accredited in procedures related to processing, storage and issue of human haemopoietic progenitor cells: Accreditation No. 19786, operating in
- RCPA quality assurance program
- ISBT 128 registered and compliant since 2008
- FDA Registered since 2006
Personnel
- Fully trained, specialist personnel with documented competencies in facility operations, manufacturing, testing and quality
- Clinical Quality Management personnel with extensive regulatory compliance experience
- Strong, respected working relationship with national regulatory agencies and policy development authorities