Low molecular weight active substances
Impulse project: SM²all - Low Molecular Active Ingredients: Production, Analysis, Safety, Efficacy
SM²all addresses drug discovery as well as drug manufacturing and sets new standards to increase the international competitiveness of Germany as a research and production location in this field. The project modernizes the entire process chain of drug production from process development to drug testing for small molecules and biopharmaceuticals. SM²all creates an innovative technology platform for multimodal process and product analytics and builds innovative cellular assay systems to evaluate the safety, efficacy and cellular uptake of drugs. The main objective of the project is to produce active pharmaceutical ingredients in a safe process (minimization of quality fluctuations) without subsequent offline testing and to test their function in cell cultures through the innovative combination of automation techniques, online measurement and online analysis technology. Such a continuous and safe manufacturing process based on microreactors increases patient safety and reduces manufacturing costs.
The project sets two decisive impulses for the Rhine-Main-Neckar region as a production and development location. The first is multimodal process and product analytics for high-quality drug manufacturing processes and is divided into several steps. At the beginning is the investigation of continuous manufacturing processes, with which the active pharmaceutical ingredient production can be optimized. For plant planning, virtual engineering is used. Another focus of the SM²all project is to improve process development through intelligent online sensor technology involving and linking various optical/spectrometric technologies. The question of how the process development time can be shortened, it will be important to automatically capture relevant parameters. SM²all will also develop optimized, continuous product processing and purification and a multimodal analytics platform to study the safety-related properties of biopharmaceuticals.
The second impetus focuses on setting new standards for preclinical drug testing by building an extensible test system. The system is intended to enable the safety assessment and efficacy of drugs on one- and three-dimensional cell culture models and to record the uptake of the active ingredients.
The individual innovative components of these two impulses are being researched in the context of SM²all with various company partners. As an overall concept, the project with its approach represents important elements of the development process in a "virtual" company. Over the next few years, the work in SM²all is to establish a novel industrial production process based on continuous production and online process control.
With the planned automation of processes and networking, SM²all is making an important contribution to the development of Industry 4.0.
Impulse Project SM2all
Project Leader: Prof. Dr. Thorsten Röder
Cellzome GmbH is a biotechnology company that spun out of the European Molecular Biology Laboratory (EMBL) in Heidelberg in 2000 and was acquired by GSK in May 2012. Cellzome is a leader in the field of chemoproteomics.