TIA enables access to expertise relevant to multiple therapeutic modalities. Each area is supported by a dedicated broker/facilitator with expertise in therapeutic development who can help you get the support you need.
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TIA supports access to production of of viral vectors (inc. lentivirus, adenovirus and adeno-associated virus) to support preclinical proof-of-concept work to develop strategies for targeted delivery of advanced cell and gene therapies to specific tissues. Expertise includes capsid optimisation to improve tissue specificity, and developing improved vectors leading to better titres. The quality of production is controlled by extensive QA procedures.
Process and QA development for cell & gene therapies
Extensive expertise in developing manufacturing and QA processes for manufacture of advanced therapies for medicinal trials
TIA facilities have extensive experience in developing robust and reproducible processes for scaled-up manufacture of advanced therapies for clinical trials and patient use. This includes identification of suitable supply chains for raw materials and transferring a bench-based process to a closed system. TIA facilities offer access to state of the art, industry-standard equipment such as Xuri, Prodigy, and other advanced suppliers.
Quality Assurance is a critical and often overlooked step in process development. Ensuring that the critical quality attributes of a product are identified and well characterised is paramount, as is in-process and release testing for identity, potency and sterility. TIA facilities are experienced in expert across the whole range of required capabilities and can assist you in scaling up your process.
GMP/Phase I-enabling manufacture
Production of novel therapeutics for clinical trials at quality-accredited facilities
TIA supports a suite of GMP facilities that manufacture high quality biologics, vaccines, RNA, viral vector and cell therapies. These facilities will work with you to develop manufacturing processes suitable for Phase I clinical trials and beyond. With in-depth understanding of regulatory requirements (TGA, FDA, ISO9001, FACT), the facilities can advise on best practice and provide documentation to support regulatory processes.
Development, manufacturing and regulatory advice
Advice to help you translate your research discovery into a potential medical product
Developing novel therapeutic products is risky, expensive and takes a long time. TIA facilities can help you understand the many steps involved in developing your product, reducing risk and improving the pathway to commercialisation.
Having lived experience of navigating regulatory pathways, and working with industry partners, TIA facility staff are a great resource to help you understand the necessary steps towards starting a clinical trial and making complex regulatory submissions.
Establishing quality systems
A library of documents to help you develop an in-house quality system
A fit-for-purpose quality system is crucial to ensure reliability and reproducibility of results, and is a prerequisite for accreditation under many internationally-recognised codes of practice. When setting up a quality system for the first time, TIA has brought together a suite of documents, named iQDOCs, with generic examples of documents relevant for each of the common standards, from ISO9001 to FACT and TGA-licenced GMP. Our facilities work within phase-appropriate quality frameworks relevant for their needs and these documents can also assist in establishing, maintaining or build your quality system.