To mark its 10th anniversary, Drug Discovery & Development magazine invited industry vendors to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.
innovatis AG
Headquarters
Bielefeld, Germany
Location(s)
Singapore, Philadelphia
Web site
About the company
Innovatis in Bielefeld, Germany, developed the first fully automated cell counting system in the 1990s, the Cedex. This product soon afterwards revolutionized the market as it replaced manual cell counting in most international laboratories in the pharmaceutical industry and it became the Gold Standard.
Driven by its vision to be a global leader of innovative technologies in the biopharmaceutical market, innovatis expanded its product line and services. Multiple critical parameters of biopharmaceutical processes can now be measured fully automated and mostly online and in real time.
The company’s line of business as it was 10 years ago. Changes in life science/drug research that influenced business.
The key invention, the Cedex Cell Analyzer, revolutionized the cell counting process. Since the company name is its vision, innovatis developed state of the art technologies and services. Driven by PAT initiative and QbD projects, the biopharmaceutical industry moves more and more to a scientific approach in development and manufacturing. This has been foreseen and, since the trend is now program in biopharma, the technologies and services are serving benefits beyond simple cell analysis. The dream of innovatis founders, to fully automate cell analysis and to monitor the process in real time online, now becomes true.
Scientific challenges in the next 10 years.
Quality by design is the first step to increase process understanding and accomplish consistent process improvement. However, we are still far away of real time process adjustment based on comprehensive process understanding and consistent real time monitoring of all critical parameters. The challenge will be to identify all critical parameters, to transfer that knowledge to all teammates and to develop tools that are useful to understand the interrelations between all of them. As more transparent the processes are and as more data for process monitoring will be acquired as more complex the process seems to be. It’s key to offer tools to the individuals that help them identifying process improvement capabilities and to still stay compliant to requirements of regulatory affairs. Since Real Time Release is the main objective both the pharmaceutical industry and regulatory affairs have to stay in permanent dialog to achieve it without leaving the right path.
Factor(s) that drove the development of technologies during the last 10 years and greatest area of growths.
Mainly the factors below have driven the technology:
- Increase of Global Collaborations and Alliances
- Significant increase of biomanufacturing capacities
- Trend of Contract manufacturing and Contract research
- QbD and PAT initiative
- Cost pressure of pharmaceutical industry
- Increase of process level of process automation
Since real time monitoring and data sharing is key to improve processes combined with the need of more global communication ONLINE Analytic and Data Management will be the key areas of growth.
Bold Prediction: Where will drug research technology be in 10 years?
The understanding of interactions and pathways will be significantly increased. Simultaneously there will be more an industrial type of approach in research. That means: scientists will use more tools to simulate processes and to run theoretical models before they start developing processes in “real life”. It can be compared with the automotive industry where they are already simulating impacts of constructive chances to the driver security before they drive the car against a wall in the crash test. Scientist will handle significant more data and they have to find a way to identify the right data that are worth to think about and make them to helpful information.
