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Services include cloning of hybridoma sequences and production of chimeric antibodies, reformatting to antibody fragments (scFv or Fab) or from fragments to whole antibodies and production of bispecific antibodies and antibody fusion proteins. Engineering of the antibody constant region to manipulate effector function and enhance antibody stability is also accessible. Facilities can provide advice on potential strategies for therapeutic development of “non-human” antibodies for further use. 

Antibody discovery services, utilising an in-house naïve human phage display scFv library, are also available. The facility has a track record in isolating antibodies against a variety of therapeutic targets, including purified proteins, cell surface antigens and peptides. Once scFv fragments are isolated, these can be engineered into whole antibodies of various isotypes. 

TIA’s small molecule drug development pathway is supported by industry-standard and cost-effective compound library management and logistics to support high throughput screening. Compound libraries available in assay-ready formats include open access collections (drug libraries, academic library, scaffolds library), closed access collections (proprietary collections) and specialised collections (NatureBank and Australian Lead Identification Consortium).

The success of the COVID-19 mRNA vaccines has demonstrated the potential of RNA vaccines and therapies. Over the next decade, RNA is poised to become a central drug platform for treating a wide range of human diseases.

Accessible services include RNA design, plasmid amplification and linearisation, RNA manufacture (1-5mg), and the necessary analytics to ensure a high-quality product. RNA manufacture is supported by appropriate quality systems that enable best-practise standards, ensuring documented and robust, scalable processes.

Current production capabilities include:

• pDNA (sub mg to +10 mg)
• mRNA (up to ~100mg)
• Small RNAs (eg. siRNA, 5 to 500 mg)
• Oligo RNA/DNA (up to 100 nt)

TIA Biologics nodes offer multiple expression systems for industrial biotechnology and biologics production ranging from microbial, yeast, insect, or mammalian cells. Applications include pharmaceutical development, diagnostics, enzymes, and biotransformation/biocatalysis.

Facilities use automated systems such as the Beacon by Berkeley Lights to accelerate identification and outgrowth of single cell-derived clones. The platform considers manufacturability endpoints through coupling with high throughput assays to screen for high producers and associated characterisation analysis to ensure lead clones meet required process and product quality attributes.

We have over a decade of experience assisting clients in translating their novel therapeutic targets into biologics that can support clinical end points, by ensuring we always focus on quality in developing and selecting a panel of lead clonal cell lines.

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.

TIA enables access to a network of advanced high and ultra-high throughput screening centres across the country, including a broad range of assay technology and supporting expertise. Libraries of up to 300,000 novel compounds can be screened in a few days, and identified hit compounds can be rapidly identified for further investigation.

As programs move from development to the clinic, it is imperative to establish a data package around each of the upstream, downstream, and supporting analytical testing needs to reproducibly manufacture a protein of interest.

TIA Facilities offer access to a full spectrum of industrially relevant capabilities to develop and optimise upstream and downstream manufacturing processes. Single-use product-contact surfaces help mitigate the risk of cross-contamination and improves efficiency, with scaling options from bench up to 200 L.

We develop and tailor purification strategies to ensure that the end product is stable, fit for purpose and meets purity and safety requirements, from simple affinity-tagged research-enabling milligram protein preparations to gram quantities from Phase I-enabling bioprocesses. Process development is supported by state-of-the-art bioanalytics and method development expertise to build a data packages around thermal stability and assessing protein quantity, purity, and quality.

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.

To function in vivo, RNAs requires a safe, effective and stable delivery system to protect the nucleic acid from degradation, for targeted delivery, and allow uptake into cells and subsequent release. Lipid nanoparticles are the most currently successful platform and have been used for COVID-19 vaccines. TIA facilities can offer expertise and experience in the development and formulation of lipid nanoparticles (LNPs) that enable the clinical delivery of RNA molecules.

TIA’s facilities offer specialised multi-disciplinary services in early-phase drug discovery and development, incorporating medicinal chemistry and ADME-guided lead optimisation to multidisciplinary drug discovery teams for improved compound design, selection and progression. Services include medicinal and synthetic chemistry, hit-to-lead activities, structure-activity relationship probing, physicochemical profiling, drug metabolism, in vitro biopharmaceutics, in vivo pharmacokinetics and bioanalysis using LC-MS/MS.

A novel and highly potent class of drugs known as antibody-drug conjugates (ADCs), utilises molecular chemistry to combine potent small molecules with mAbs that can combine the advantages of both modalities. TIA’s Biologics nodes have extensive ADC experience and in generating effective strategies around the manufacture, chemical linker design, purification, and characterisation of similar radio-labelled or high-potency bioconjugate molecules and diagnostics.  

TIA offers access to advanced preclinical disease models in NATA-accredited facilities. With a particular expertise and experience in the field of pain, the services can be used to screen new molecules for analgesic activity and to probe the pathobiology of individual human pain conditions. The accredited mature of the facilities means that the resulting data is investor- and regulator-ready.

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.

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.

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.