PLATFORMS & WORKFLOWS
We modernize the manufacture of pharmaceutical products through our development of novel platform technologies and standardized workflows. Our work facilitates a rapid adoption of more efficient technologies and mediates strategic risks of implementation. We closely follow the ‘Advanced Pharmaceutical Manufacturing (APM)’ approach. This means processes have to be (I) controlled, (II) understood), (III) robust, (IV) intensified, (V) scalabe and (VI) cost-effective.
Our research has the following focus:
Continuous manufacturing and processing gradually changes the way we manufacture pharmaceutical products. Replacing predominant batch processing, enables the industry to utilize shorter lead times and to increase sustainability of manufacturing process.
Since our inauguration we have developed the technological foundations in order to allow the industry to benefit from continuous setups. In interdisciplinary research projects we facilitate the holistic understanding of various processes, the impact of material characteristics and associated quality control. With our exceptional Pilot Plant we can directly validate theory and assure effective technology and knowledge transfer.
Originally adapted from the plastics industry, hot-melt extrusion allows the therapeutic utilization of poorly solubles or instable molecules. By combining the molecule with a bioactive polymer the functional properties can be modified and adapted. This methods is particularly interesting for enteric dosages, products with sustained release profiles and/or taste masking for patient-centric formulations. As one of the leading research centers for this technology, our work will enhance the field of application to also encompass products with small processing windows and that are sensitive to degradation.
The intended design and manufacturing of optimal particles, may it be in shape, size or any other property enhances the function and therefore ensures the therapeutic success.
RCPE researches and applies various approaches us as spray drying, milling and micronization as well as continuous crystallization. In close relation to our work on inhalative medicine and taste masking, we enable the development of patient-centric medicines for pediatric and geriatric applications and provide pharmaceutical companies with the capability to modify their products to meet the individual needs of these patients. At RCPE we are working on a technology platform for taste masking that involves formulation design (using different lipids and polymers), fluid-bed coating engineering and real-time control of coating thickness via our optical coherence tomography.
PRINTING & SMALL-SCALE MANUFACTURE
Personalized and individualized medicines are becoming increasingly important as an alternative manufacturing route. This development is a direct consequence of fast sequencing, high-throughput analysis, improved imaging and better understanding of genetic factors. Enabling the patient specific combination of active ingredients, in optimally dosed amounts promises to increase therapeutic performance while limiting side effects. The manufacturing of those highly individualized dosage forms remains challenging.
In this particular area, RCPE focuses on the development and enhancement of 2D printing. We hope to accelerate translational drug development und to improve pre-clinical and clinical testing through the facilitation of rapid bench-to-beside testing.
The utilization of databanks and other tools which can be filled with reliable data from standardized measurements can accelerate the development and screening of formulations. Pharmaceutical companies can streamline their development and focus on the most promising options.
Within our research work, the RCPE has conducted numerous measurements and characterizations of various materials, their properties and their impact on critical process attributes. By making this knowledge accessible we create a powerful tool for rapidly evaluating and selecting of formulations for several manufacturing processes.