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Cell & Gene Therapies

TIA brings together five key national cell and gene therapy development and manufacturing facilities (shown in the map below) to facilitate the translation from discovery to clinical benefit. Our consortium of CGT facilities has far reaching expertise to support and assist your development across the spectrum of cell and gene therapies regardless of your stage of development.

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Available expertise

Cell, Tissue and Gene Therapies

Therapeutic paradigms including, but not limited to induced pluripotent stem cells, mesenchymal stromal cells, autologous and allogeneic CAR T-cells, gene therapies for rare diseases, tissue engineering and 3D bioprinting.

Process Development 

The facilities can provide expert review of your cell or gene manufacturing process to streamline your manufacture in preparation for clinical trials.

GMP Manufacturing

TIA offers TGA licenced GMP manufacturing in clean rooms across Australia of gene therapies and cellular products for clinical trials and commercial use.

Quality Control

The highly personalised nature of many of the cell and gene therapies requires unique quality control tests for each therapy. The facilities can offer in process and for release quality control testing. They will be able to identify QC tests required and assist in work up of specific tests for your product.

Regulatory Experience

All the facilities have experience in multiple regulatory bodies including TGA (Australia) and FDA (US). They can offer suggestions on how to manufacture your products for successful application to the different regulatory authorities.

Science Lab

We have developed two guidance documents to assist you in translating your research discovery into an advanced therapy medicinal product.

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CROSSING THE VALLEY OF DEATH : Guidance for Translating a Research Discovery into an Advanced Therapeutic Product

Key messages:

  • It is never too early to reach out to the facilities within TIA’s Cell & Gene Therapy Capability for advice on making the transition from research to development.

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  • Early engagement with TIA or one of the facilities will enable you to leverage their significant expertise and expedite your translation to clinical development.

 

  • Understanding GMP requirements early will save you time and money.

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TRANSLATION FROM  DISCOVERY TO MARKET: Guidance for Translating a a therapeutic candidate to a commercial product

Key messages:

  • Translation of your product out of the lab and into clinical development will require a shift of mindset from research curiosity to process reproducibility

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  • You will need a robust, reproducible manufacturing method for tech transfer to a GMP grade facility

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  • The quality, safety and efficacy of the product will be interrogated, defined and documented during translation and tech transfer

 
Do you have a technical problem or a research need? Reach out to us by completing the enquiry form and we will endeavour to find you the right connection. 

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