From innovative technology to marketable in-vitro solution
- Suited for challenging environment (incubator with high humidity and limited space)
- In vitro-technology
- Successful collaboration with CoBioRes, a biotech company focusing on minimizing side effects of chemotherapeutics
In a nutshell
The development of a new pharmaceutical drug candidate requires years of research. During the preclinical phase, the effectiveness of a candidate drug on in vitro cell culture cells is measured. With CellSine’s I-series device, co-developed by Comate and Unitron, this can be tested quicker and more efficiently. Since well-performing lead molecules are selected earlier in the process, the process can be accelerated and costs can be reduced. In this way, medication could get to the patient faster with less testing on animals required.
The full story
When a drug is in development, it goes through several phases that are often time-consuming. Before starting clinical trials, in which the drug is tested on humans for the first time, researchers examine the effect of the treatment on cells or animals. A new technology based on electrochemical impedance spectroscopy (EIS) was developed as part of a doctoral research project at the University of Leuven (KU Leuven) and the University of Brussels (VUB). The technology uses small, alternating currents through a biological system, which makes it possible to determine the impedance. By doing this at different frequencies, the measured impedance can be correlated with changes in biological processes.
This electrochemistry is used to analyze the behavior of living cells. A typical application of this technology is investigating new drugs. This involves seeding mammalian cell cultures (usually mouse or human origin) into a 96 well plate, and using innovative technology to measure the effect of potential drug candidates on these cells. The in vitro technology makes it possible to make a high-content analysis of the living cells within a few weeks. Well-performing molecules are detected earlier, which accelerates the process and reduces costs.
In addition, the in vitro technology ensures that the number of animal tests required can be significantly reduced. Certain side effects or toxicity can already be observed in vitro, which means that at this stage it can be determined that the drug candidate will probably not be suitable for testing on animals.
From PoC to a market-ready product
The doctoral study resulted in a proof of concept test setup that demonstrated the effectiveness of the technology in a lab environment. However, the test setup was not ready to be released on the market and had to evolve into a market-ready product first. The collaboration project between KU Leuven and VUB, named CellSine, was set up to bring this innovative technology to other companies and thus exploit its full potential.
CellSine relied on the expertise of Comate’s engineers and designers for the technical development, to translate the PoC into a market-ready product. “Working together in a collaboration of this kind is always interesting. They spent years doing research to come up with an incredible technology. This level of expertise is also present at CellSine. They use top-level technology,” says Sander Van den dries, co-manager at Comate. “They already built a Proof of Concept, but there is still a big difference between a lab setup and a market-ready device that you can bring to market in large quantities. If they have to learn all that, they will be busy for years. Our added value lies into our ability to convert their concept into a market-ready product. This is a good example of how the expertise of different partners complements each other nicely”.
One of the first steps in the product development process was to determine which requirements the device definitely had to meet. The product would consist of two connected parts: the main unit and the docking station. From a technical point of view, there were many things the team had to take into account, as the docking station would be placed in a special environment. During candidate drug effectiveness testing, the device is placed in an incubator for a longer period of time. In this incubator, the temperature is 37 degrees Celsius, there is a high humidity and there is usually limited space available for placing and operating a device. Since the initial choice was to go for a low print run, the team also had to exclude certain materials because of their expensive production techniques.
The challenge was to develop a system in which electrical sensors could perform certain measurements without exposing the electronics to moisture. A good connection between the electrodes of the docking stations and the well plate is crucial for an optimal operation of the device. Only when these requirements are met, a correct reading of the impedance measurement is guaranteed. In addition, the ability to easily move the well plate in and out of the docking station, even if placed in an incubator, was also very important.
On top of the technical excellence and flawless operation, it was crucial that the device was user-friendly. It was especially important that the device was easy to maintain and clean, as sterility and hygiene are very important factors in a research lab. In addition, a design that fits within a lab environment was needed.
From analysis to industrialization
Comate’s engineers worked on various concepts. In order to select the best proposal, several mock-ups were made during the analysis phase. In this way, very valuable feedback could be collected in a cost-efficient way. During the system design, usability tests were carried out to ensure optimal ease of use. Finally, a system was chosen in which the well plate is placed in the docking station and a hinged lid pushes the well plate against the electrodes when closing.
During the integral design phase, the design was fine-tuned and optimized. A series of renders were made, so there was a clear picture of what the device would look like, before its production. During the final phase, the prototype was transformed into the final product that was ready for industrialization and large scale production.
Optimization and efficiency boost for healthcare
CellSine’s device allows candidate drugs to be screened more efficiently, making development faster and cheaper so patients have faster access to them. Within a few weeks, a high content analysis can be carried out on different cell types, which makes it possible to quickly select the molecules with the highest chance of clinical success in a preclinical phase.
After creating product awareness with potential clients through different types of publicity, commercial adoption by end users started in 2019. A fee-for-service system was setup in which CellSine develops and conducts experiments in close consultation with clients. For example, a collaboration with CoBioRes, a biotech company focusing on minimizing side effects of chemotherapeutics, resulted in the development of an in vitro potency assay for an angiogenic growth factor. In addition, Nutramosam used CellSine technology to monitor various types of cellular behavior, such as cell adhesion, proliferation, receptor activation, as well as calcification processes. This helped them to accelerate future nutraceutical screening assays.
Personalized medicine & Artificial intelligence
CellSine has clear ambitions for the coming years. Their device is linked to special data analysis software that allows users to obtain large amounts of information from a test that requires only a small investment of time. A wide range of cellular behaviors can be measured and visualized in real-time. CellSine’s ambition is to integrate artificial intelligence into their data analysis software in the coming years.
In the coming years, the company also wants to give personalized medicine a boost. The effects of medication are different for every patient, as it depends on genetic factors, nutrition and health. Personalized medication increases the chance of success of the treatment, while costs can be reduced. The efficiency of the entire healthcare system can thus be greatly increased. Together with lifetech.brussels, CellSine is currently investigating how to use its expertise to develop personalized cancer treatment based on the patient’s own tumor cells.
For more information about CellSine and other possible applications, visit https://www.cellsine.com/.