Cell and Gene Therapies Capability

TIA brings together five leading cell and gene therapy development and manufacturing facilities in Australia to facilitate the translation from discovery to clinical benefit, ensuring that manufacturing occurs in compliance with regulations and that products entering clinical trials are of a sufficiently high standard.

The development and manufacture of cell and gene therapies is highly complex. Often, there are many questions that will need to be answered during the development process.

 

To help you be better prepared for translating your research to GMP manufacturing, TIA has drafted a guidance document focuses on technical questions. 

Click here to download the document.

TIA has partnered with CCRM Australia, an organisation that accelerates the commercialisation

of Australian regenerative medicine therapies and related technologies.

 

CCRM achieves this through engagement and fostering local and international collaboration between industry, clinicians and academia.

Capabilities​/ Services offered

  • TGA-licensed manufacture of regenerative medicine, CAR T-cells, tissue engineering for clinical trials

  • Translation from academic research to clinical manufacture

  • Quality management advice and consulting

  • Clinical interface and clinical trial support

  • Controlled storage & preparation for administration of cell & genetically modified products

  • Non-viral gene transfer and editing technology

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Cell and Tissue Therapies WA 

 

Q-Gen Cell Therapeutics 

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Capabilities​/ Services offered

  • TGA- licensed GMP manufacture of immune (Phase I-III) and non-immune cell therapies (Phase I) for pre- clinical/clinical trials

  • TGA- licensed GMP microbiological and immunological testing to support manufacturing

  • Process development and technology transfer for cell therapy manufacture and QC testing

  • Development and manufacture of viral vectors to support cell therapy manufacture (in development)

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Cell & Molecular Therapies, RPA Hospital

Capabilities​/ Services offered

  • TGA- licensed collection and processing of cell therapies

  • Manufacture/formulation of GMP cell and gene therapy products for Phase I-III trials.

  • Contract manufacturing of cell therapies for early phase trials

  • TGA- licensed controlled cryopreservation and monitored cryostorage

  • Process development and technology transfer

  • Quality control testing for release of products

  • Quality management, GMP and clinical trial consulting services

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Sydney Cell and Gene Therapy 

Capabilities​/ Services offered

  • Development of gene therapy vectors

  • Quality management to enable GMP compliance

  • Process development for cell therapy manufacture and QC testing

  • TGA- licensed manufacture of pathogen specific T cells for clinical trial and commercial supply

  • Translation from early phase clinical trials of cellular immunotherapy to ARTG listing

  • TGA- licensed compliant site for future production of pathogen specific and CAR T products

  • Expansion of CAR T cell therapy clinical trials into new trials to target paediatric solid tumours

 
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Centre of Excellence in Cellular Immunotherapy

Capabilities​/ Services offered

  • TGA-licensed GMP manufacture of cell therapy, gene-therapy, cellular immunotherapy and regenerative medicine products for clinical trial and commercial supply 

  • TGA-licensed GMP controlled storage, distribution & preparation for administration

  • TGA-licensed GMP microbiological and immunobiological testing

  • Process development to translate pre-clinical models to clinical-scale manufacturing process

  • Apheresis collection process development

  • Consulting services to support regulatory strategy, trial development, manufacturing and quality systems

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