The manufacturing of biologics with consistent quality is challenging. Since the quality of biologics is impacted greatly by the cell culture process, the robustness of this process must be maintained in the face of variability in raw materials, production equipment, or even production sites. Currently, a deviation in the cell culture process is discovered only after it occurs and may result in batch failure. It is therefore highly desirable to predict any deviation early in the process which would enable corrective and preventive actions.
The Insilico Advisor predicts cell culture performance and flags future deviations. Further, it also advises actions to correct and prevent the deviations. Thus, the Insilico Advisor enables model predictive monitoring of cell culture processes to increase the reliability and consistent quality of biologics manufacturing.
Klaus Mauch, CEO of Insilico, says: "Most people are aware of challenges in drug development. The long timelines, the high failure rates and high-stakes clinical trials are all common knowledge. However, most do not appreciate the challenges in manufacturing of approved drugs. Especially, manufacturing of biologics of consistent quality from living cells is very tricky. By enabling model-predictive monitoring, the Insilico Advisor reduces batch failures and provides information for root cause analysis if a failure does occur. We are happy to add the Advisor to our suite of products as our first solution for manufacturing-related challenges. We expect that it will lead to leaner manufacturing and ultimately to consistent quality and cheaper drugs for patients.“
Insilico Biotechnology AG develops and delivers predictive Digital Twins to advance biopharmaceutical process development and manufacturing. Insilico Digital Twins of cell culture processes lead to superior productivity, product quality and process robustness. Ground breaking predictive power is achieved by exploiting process data using artificial intelligence and biochemical networks. As a result, Insilco’s unique approach substantially reduces experimental effort, costs of goods and time to market. Leading biopharmaceutical companies worldwide use Insilico Digital Twins for cell line development, media design and process control. Founded in 2001, Insilico Biotechnology is a privately held company based in Stuttgart, Germany.