Understanding active ingredients
How fast can a vaccine be developed and produced on a large scale? The spread of the novel coronavirus has focused more attention on this question than ever before. Bilfinger is currently collaborating with an international biotech company on a pilot project aimed at increasing the efficiency of new active ingredient development.
Long columns of numbers, complex data curves and regular process comparisons – employees at the research center in Switzerland have an eye on everything. Their work includes developing active ingredient candidates for treating cancer. They can now monitor the production of cell cultures in a bioreactor from a computer in real time. Perfect conditions are required to grow cells in a bioreactor. “Temperature, oxygen supply and nutrient content all have to be finely balanced in order to produce an active ingredient of consistent quality,” explains biotechnologist Dr. Wolfgang Sommeregger. To effect optimum control of the many parameters in this complex process, he and his team at Bilfinger have developed a software solution in cooperation with the Institute of Bioprocess Science and Engineering at the University of Natural Resources and Life Sciences in Vienna. Among other things, the software facilitates integrating spectroscopic measurement techniques and apply mathematical models in real time. This means customers can automatically calculate key performance indicators at any time and harness these data in controlling the process. Any deviation from the specified reference range immediately triggers an alert, leading to an instant automatic action or enabling operators to intervene manually in the production process. This concept is referred to as “Quality by Control,” which inspired the name of the software: Qubicon.
All data on a single platform
One focus of the pilot project is the integration in a central platform of all the data generated in day-today laboratory and production operations. Ideally, this allows developers to identify process correlations that were previously undetectable. Customers can use the system autonomously but may also consult Bilfinger’s experts, such as the team be hind Dr. Sommeregger, at any time for advice. The success of the software platform is measured above all by the efficiency and reproducibility of the process and by the consistent quality of the active ingredient.
The software is one of the latest innovations from Bilfinger Life Science GmbH. In developing the software, the company applied its extensive pharma expertise based on decades of experience in planning and installing pipelines and production equipment for the biotech and pharmaceuticals industry. The product portfolio includes bioreactor systems and fermentation equipment as well as solution preparation, ultra-pure media, purification and CIP/SIP systems.
Additionally, Bilfinger supports its pharmaceuticals industry customers in expanding and modernizing their production facilities and reducing maintenance costs. Siegfried AG, headquartered in Zofingen, Switzerland, provides a case study of what can be achieved. Bilfinger is responsible for maintenance and engineering at the company’s production units. This has resulted in a reduction in annual maintenance costs of more than 30 percent, from previously over CHF 12 million to under CHF 8 million today. “That demonstrates the great potential offered by the Bilfinger Maintenance Concept to customers in the pharmaceuticals and biopharma industry,” says Gerald Pilotto, Head of Global Development at Bilfinger. It allows pharmaceuticals manufacturers to better focus on their core business, namely the development and production of active ingredients.
Three questions for Gerald Striedner
Professor Gerald Striedner is Deputy Head of the Institute of Bioprocess Science and Engineering at the University of Natural Resources and Life Sciences in Vienna and has provided academic support for the research project to develop Qubicon in cooperation with Bilfinger.
What potential do you see for a software solution like Qubicon in the pharmaceuticals industry?
The market for biopharmaceuticals is marked by very high growth rates with a large number of newly approved active ingredients. However, the products are expensive and thus exert enormous cost pressure on public healthcare systems. Ensuring that these drugs are widely available to society can only be achieved by significantly reducing manufacturing costs. This is why the authorities and industry have devised an approach for the direct in-process control of product quality. Intelligent software solutions such as Qubicon are of elementary importance here. This new approach to quality assurance will likely be accepted and become the recognized standard in pharmaceuticals production.
Why are solutions like this not yet in widespread use?
Implementing them represents a major interdisciplinary challenge and many pharmaceuticals manufacturers, software developers and engineering companies have already developed their own solutions for certain segments. However, until now, there was no all-in-one software solution like Qubicon on the market that unifies, stores, processes and analyzes all data in one system and enables automation. Drawing on its expertise in biopharmaceutical plant equipment, Bilfinger has developed the software to allow flexible integration into existing systems and precision tailoring to customers’ needs.
You’re already working on a follow-on project. What is its objective?
We’re looking at continuous production processes and fullscale integration of the individual process steps – from the cell culture through separation of the product from the cells to final purification of the product. The software will be enhanced for use in the fully automated, continuous production of biopharmaceuticals.