During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
The biopharmaceutical industry requires a more efficient supply chain that enables it to make predictions about the problems associated with developing novel biotherapeutics and to help reduce the risk and cost of commercialisation. This has the potential to offer patients access to a wider range of affordable and effective drugs by limiting the amount of resources wasted on unsuitable molecules. The BioStreamline project mitigates these biotherapeutic development challenges, offering a unique approach that uses state-of-the-art technologies to provide developers with a better understanding of candidate molecules earlier in the development process. The outputs of the BioStreamline project should allow developers to make better informed decisions about which molecules to progress, to address currently unmet medical needs.
BioStreamline is a collaborative project which brings together complementary assets and cutting-edge expertise from six partner organisations across the spectrum of drug discovery and development, with funding from the UK Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI). The six partners were Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI.
The project involved the following major areas:
- The development of Sphere Fluidics’ novel single cell analysis and monoclonality assurance system (Cyto-Mine®) and associated methodologies. This enables the screening and isolation of valuable, rare B cells for antibody discovery and high-expressing single cells for cell line development, helping to increase the speed and efficiency of entry into the biologics supply chain.
- Investigating new approaches to cell line development by using Horizon’s CRISPR gene editing expertise to create cell lines that display specific phenotypes, including increased productivity.
- Collecting developability data derived from an initial set of over 200 monoclonal antibody sequences, down-selected to a defined panel of 50+ monoclonal antibodies. These antibodies are produced, purified and analysed, and biochemical, biophysical and stability data on the molecules collected, which is then used together with other inputs to create an agile, flexible and improved approach to biotherapeutics developability.
- Preclinical assessment of the immunogenicity risks of biotherapeutics, to minimise exposure of human patients to potential safety risks during early clinical trial development.
John Liddell, Chief Technologist, CPI, said: “We are very excited by the success of the project and feel that a similar approach could be used with other therapeutics, such as viral vectors, which are rapidly emerging as major therapeutic areas. The level of investment that AMSCI has made to this area has provided sufficient breadth of scope to increase understanding of this important aspect of biotherapeutic development, and we are looking forward to presenting the outcomes at the event later this month.”