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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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.
Extensive experience and capacity producing and selecting cell ines to express a wide range of proteins
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.
Process development for biologics
Assessing and improving "manufacturability" of biotherapeutics in terms of quality and yield, in preparation for GMP manufacture
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.
Expertise in bioconjugation techniques to produce antibody-drug conjugates for targeted delivery of drug payloads
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.
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.