Enough experimenting! The KIT spinoff GoSilico enables the biopharmaceuticals branch to introduce the computer-supported development of manufacturing processes for new agents.
The way from the discovery of a promising agent to its authorisation is tedious. It involves countless experiments that not only cause high costs but also require a considerable amount of perseverance. “It can take up to ten years for a drug to enter the market,” says Dr Thiemo Huuk. This is a shortcoming that he tends to address together with his co-founders Prof Dr Jürgen Hubbuch, Dr Teresa Beck and Dr Tobias Hahn.
Together, the four researchers have founded the KIT spinoff GoSilico. They are developing software and methods for computer-supported process development in bio-pharmaceutics. The core of the spinoff is ChromX, simulation software with which the steps in developing manufacturing process for bio-pharmaceuticals can be illustrated by the computer in a matter of seconds – which would otherwise take days or even weeks in the laboratory. Ninety-five per cent of the laboratory experiments could be replaced by in-silico technology. The term “in-silico” refers to computer-supported process and relates to the chemical element silicon, with which a major share of today’s computer chips are manufactured.
However, saving money and time is not the only advantage that GoSilico offers. Processes can be simulated under a wide range of influences – also in extreme situations. For example, testing robustness can be accomplished far more quickly, which is a crucial contribution to complying with pharmaceutical regulations. Ultimately, the simulation technology developed by GoSilico therefore also supports risk reduction.
The notion of ChromX already developed in 2011, when Tobias Hahn and Thiemo Huuk were doing their doctorates at the Institute of Process Engineering in Life Sciences (BLT) under Professor Jürgen Hubbuch at KIT. Through cooperation on an open-source software with Teresa Beck, who was pursuing her doctoral studies in mathematics at the University of Heidelberg, the four-member founding team was finally formed in 2015. Tobias Hahn recalls: “When we started our research, nobody considered going into business. The software was originally conceived as an academic research tool.” It was only when more and more inquiries were coming in on commercial utilisation that founders Hahn and Huuk started thinking about licencing the software and making it available for purchase.
After that, one thing followed another. During an Entrepreneurship Summer School at the KIT Institute for Entrepreneurship, Technology Management and Innovation (EnTechnon), the team developed an initial business model. This was followed by taking part in the KIT Accelerator Programme upCAT, in which the prospective entrepreneurs had the opportunity to further elaborate their business plans and present them to business angels, businesses and investors. “As scientists, we now had to learn how to take a look at our project from an entirely different angle. All of a sudden, what counted was not to have a solution ready for every eventuality but to test the product on the market and attract pilot clients. At the time, a mentor advised us: ‘You’ve got to stop planning and just start doing things.’ In spite of the many planning uncertainties, several items that we then developed still apply today,” says Tobias Hahn. Becoming familiar with the topics beyond their day-to-day work routine, such as business development, staff guidance and legal issues, was a challenge as well. “However, the initial difficulties also proved to be an opportunity for us to gain a valuable overview of all business areas,” Teresa Beck explains.
In addition to the software, GoSilico offers consulting and training programmes in order to ensure clients’ optimum handling of the software. As a rule, new clients start off with three-month pilot projects – a phase that requires very intensive support. “Each client envisages a different application scenario,” Beck continues. “In this phase, we are strongly guided by the requirements and standards of the respective pharmaceutical company and then develop a tailored solution based on our simulation software.” In the next few months, the team intend to further enhance user-friendliness and make the software faster and more efficient. An automation of modelling and controlling the devices is also planned. Instead of batch-wise production, this is also intended to enable continuously operating manufacturing processes.
Dr. Teresa Beck