BTI's Research Areas

Product Innovation

Manufacturability and regulatory compliance are key barriers in the path of bringing a product from the laboratory to a regulated market. These considerations impact product and process design; they can accelerate innovation if incorporated early in research.

BTI has a suite of integrated capabilities, collaborative expertise, and a network of industry partners to support product innovation. With the ability to manufacture novel products at preclinical scales, BTI is well-equipped to establish technology readiness before commercialisation. Target products include antibodies, exosomes, gene therapy, cell therapy, and alternative proteins for food.

Visit the following webpages for more information:

• Biotherapeutics Development
• Immune Cell Manufacturing
• Stem Cell Bioprocessing

CELL LINE DEVELOPMENT

The living cell harbours complexities that can be harnessed to improve the yield and quality of biological products and thereby increase cost-effectiveness. With the rise of biosimilars, dedicated efforts are necessary to create cost-competitive cell lines.

A range of genetic tools are now available at BTI to shorten timelines for cell line development. Leveraging expertise in both mammalian and microbial expression systems, BTI can optimally select and engineer cell lines to match the target application. Cell lines have been developed in-house for out-licensing, or co-developed with partners.

Visit the following webpages for more information:

• Animal Cell Bioprocessing
• Cell Line Development
• Cell Line Engineering
• Microbial Cell Bioprocessing

MEDIA DEVELOPMENT

Culture media provides a mixture of nutrients and growth factors to promote cell growth and health. It is also where desired recombinant products as well as undesired cellular waste accumulate. Critical to the performance of culture media are not only its composition and formulation but also the feed strategy: when and what to supplement or deplete from the cell culture. The complexity of culture media can significantly affect subsequent processing and thereby the overall costs of production.

By utilising state-of-the-art systems and algorithms, BTI can efficiently and comprehensively develop culture media for a variety of applications. Serum-free, xeno-free, protein-free, and chemically defined formulations have been developed in-house or with partners in industries including antibodies and cell therapy.

Visit the following webpages for more information:

• Animal Cell Bioprocessing
• Stem Cell Bioprocessing

During downstream processing, desired products from the cell culture are purified and sterilised. The choice and order of unit operations must be optimised to balance recovery versus purity, minimise cost, and maximise safety.

BTI houses a comprehensive suite of technologies ranging from cell clarification, filtration, chromatography, viral inactivation, to sterilisation, that comply with industry standards. With the addition of proprietary modes of operation, BTI is equipped to work with both conventional and niche products.

Visit the following webpages for more information.

• Downstream Processing

How a process is designed and integrated determines its overall costs and risk profile. Early validation of the performance of an end-to-end process will de-risk technology transfer to a cGMP setting.

BTI has sufficient infrastructure to integrate single- and multi-use unit operations up to 50 litres under pre-cGMP conditions. To alleviate traditional bottlenecks and improve process efficiency, BTI is developing scaled-down models to study selected unit operations and create novel unit operations.

Visit the following webpages for more information:

• Animal Cell Bioprocessing
• Biomanufacturing Devices
• Biomanufacturing Technology
• Cell Line Development
• Downstream Processing
• Stem Cell Bioprocessing

Unraveling the complexity of a bioprocess is critical to the control of product yield, quality and safety. Tools that analyse and monitor the bioprocess may ultimately serve as feedback controls to improve consistency.

BTI takes a holistic approach to enable deep and comprehensive characterisation of the product and bioprocess. Virtual models have been built to link individual components to their overall performance, permitting in silico prediction and optimisation. Novel sensors are being developed to collect real-time data.

Visit the following webpages for more information:

• Bioprocess Data Integration
• GlycoAnalytics
• Metabolomics
• Protein Analytics