CellUp business innovation project had the global objective to fix well-known key issues for the biopharmaceutical industry: costly batch failures, long lead times and associated costs for the development of complex processes and transfer to production, need for increasing productivity and capacity and too long batch release.
Currently, conventional methods are lacking: Upstream cell cultures growing in bioreactors are generally controlled in real-time only with measurements of a few process parameters, particularly temperature, pH, and DO. Current feeding strategies (nutrient supply) in mammalian cell cultures are commonly based on manual sampling once or twice per day. Downstream processes are controlled by multiple, complex, and long-lead off-line methods.
This way of proceeding, based on these conventional methods only, suffers from key disadvantages:
- Inaccurate (neither real-time nor in-situ) sampling and manual feeding introduces risk of contamination
- Routine use of off-line analytical instruments is expensive (e.g. consumables, personnel) and generally leads to long lead times, especially in DSP
- Weakness of batch monitoring makes comparison, improvement, process control, process transfer, and investigations difficult due to poor data record.
These disadvantages relate to major issues of the biopharmaceutical industry to offer reliable medicines at acceptable price whereas they mainly concern serious diseases. Improving the analytical control and automation of bioprocesses from cell cultures to formulation on the entire product cycle will have a very significant impact on this issue. This is why the major national drug agencies, such as EMA and FDA, are actively promoting the Process Analytical Technology initiative, in which CellUp intends to provide a major output.
The main objective of the CellUp business innovation project was to develop and commercialize this new disruptive in-line analytical solution for bioprocesses that the biopharmaceutical industry needs for quality and process control during the phases of process development, scale-up and manufacturing of vaccines, antibodies and cell therapies for human medicines.
This in-line analytical solution, called ProCellics™, is based on Raman spectroscopy. In terms of technological development, the above global objective of CellUp was achieved thanks to the development of a GMP (Good Manufacturing Practice) integrated hardware suite and of a GxP compliant software enabling to implement an easy, efficient and robust methodology for multivariate calibration. These capabilities were missing in the other Raman existing systems, creating a serious brake for its use in process development and for automation and preventing to be realistically used in production.
The assessment, dissemination and enrollment of the industry with CellUp ProCellics™ solution was another major successful activity of the CellUp project, with various experiments in our Upstream application lab and adoption by the development teams of major biopharmaceutical companies.
