1. What was the problem/issue being addressed?
Biopharmaceuticals are large molecules used for therapy, e.g. antibodies (mAb). The biopharmaceuticals are produced using cells in well-regulated processes ('bioprocess') in bioreactor.
Health technology is highly profitable but spending very high parts of its revenues on R&D. The development of a new drug costs about 1 billion dollars and takes ≥ 10 years. Reducing cost and time for the development of the manufacturing process gives very large savings and is essential to be first to market.
The worldwide community of bioprocessing is in quest for more rational tools to understand, predict and optimize industrial biopharmaceutical manufacturing.
2. Why was it important for society?
iConsensus aims were to bring a disruptive new technology platform for cell based production of biopharmaceuticals, to reduce the time and costs for the process development and lead to better manufacturing control. These improvements could influence the time-to-market and give competitiveness advantage, higher consistency, efficacy and robustness for the biopharmaceutical industry, generating as well reduced cost, failure and risk for product shortage.
The project clearly supported European Innovation, competitiveness and industrial leadership while giving tools to improve the European well-being and societal challenges.
3. What were the overall objectives?
Cell cultures of mammalian cells, e.g. Chinese Hamster Ovary (CHO) cells, used for the production of a biopharmaceutical are complex mixtures of ≥ 70 components, of which monitoring provide process knowledge however is a very large and tedious task. All these components can have an effect on the process performance, its purification or on the product quality, which is the reason why monitoring all these compounds is advantageous.
To address this, iConsensus provided innovative analytical, hardware, software and high-throughput solutions for the development, monitoring and control of cell culture, with an analytical platform including on-line/at-line sensors and methods measuring multiple factors. The analytical platform aimed to be integrated to bioreactor, enabling feedback control implementation.
