The development and manufacture of all Biologic drugs requires a highly productive cell line to produce these drugs, the generation of which is a complex multi-step process referred to as Cell Line Development (CLD). CLD processes are resource intensive and require lengthy timelines as a large number of cell candidates need to be screened based on multiple features (Critical Quality Attributes CQAs), with the objective of selecting the ‘Top’ clone that optimally manufactures the biologic drug of interest. The selection of a production clone is arguably one of the most important decisions made when bringing a novel biotherapeutic to patients.
In current CLD systems clones are primarily selected based on their product titer which can lead to complications in downstream manufacturing. This is largely due to the fact that assays available for CQA assessment (parameters on which clone selection is based) are restricted to clone selection later in the process, as they are simply not available in a suitable format (high-throughput, accurate, cheap, easy to use) that can be integrated at scale, earlier in the process.
iLCA brings together 3 SME partners [Valitacell, Solentim & Microcoat] to support the final market validation, and preparation for commercial take-up, of an innovative technology solution for CLD. Together, this consortium will automate the manipulation, analysis and selection of individual cells, enabling deep cellular insights in a reduced timeframe, creating scalability and increasing regulatory control for the entire biologic manufacturing process. By integrating screening for a range of CQAs into clone selection throughout upstream processing, it is possible to significantly reduce the time, cost and number of project failures associated with all stages of manufacturing.
The iLCA technology comprises a custom designed hardware platform [Solentim] with a transformative capability for the imaging and biomarker analysis of living cells when combined with a scalable consumable analytic (Fluorescence polarisation probe - Valitacell). This intelligent Live Cell Analysis platform will provide end-users with a Manufacturability index containing detailed information on their clones, which is currently only available much later in the decision making process. This two year project aims to validate the technical and economic performance of our disruptive process analytical platform at leading biopharmaceutical manufacturing sites, through full scale beta trials to deliver an industry endorsed analytical solution for the CLD process.
