The general challenges of particulate product and process design also apply to pharmaceutical and bioparticle technology, but are supplemented by special regulatory and infrastructural requirements. Accordingly, the offices and laboratories of this division of the iPAT are located in the interdisciplinary Center for Pharmaceutical Engineering – PVZ. Here, the research tasks of the iPAT division range from the biological-pharmaceutical production and purification of active ingredients to the formulation of dosage forms and the development and application of innovative processes, also in the field of micro systems and analytics.
In biological-pharmaceutical process technology, biotechnological processes from the microscopic to macroscopic scale are investigated at the interface between biotechnology, pharmacy and particle technology with the aim of improving the production of active substances. This includes increasing the productivity of microorganisms by adding particles to cultivations and enhance enzymatic processes with mostly immobilized enzymes. The consideration of microorganisms and protein particles as biological particles allows the application of findings and methods from both biological and engineering science fields. Thus, e.g. for cell walls are assigned characteristic values regarding their mechanical properties, which are otherwise only used in engineering, or also cross-linked protein crystals are examined regarding the influence of their amino acid sequence and cross-linking parameters on their mechanical properties.
In formulation and packaging technology, the division focuses on innovative formulation, characterization of manufacturing processes and the investigation of drug dosage forms. The pharmaceutically active drugs are combined with excipients via defined processes such as nano-grinding, drying, granulation and tableting – along an entire process chain – in such a way that they result in administrable dosage forms. Formulations and processes are also developed and improved to make products meet requirements such as application route, efficancy/bioavailability or release kinetics and improve these compared to conventional formulations. Here it is particularly important to investigate the process-structure-property-relationships of these processes in order to predict product qualities in future, which are physically substantiated and not based on highly empirical development. Currently, the production and further processing of active substance nanosuspensions into solid forms, coating and granulation processes as well as tableting (e.g. flow and compaction behaviour, multi-component mixtures, multilayer tablets) are being investigated in detail. Another focus is on concepts and methods for the production of patient-specific, individualized dosage forms, which are realized by 3D printing and novel methods for the production of oral dosage forms.
In the PVZ department micro apparatuses and analytics, the design and processual characterization of microfluidic systems are investigated. Moreover the formulation of drugs with the smallest amounts of active ingredients and design parameters of larger manufacturing processes (scale-up) are to be developed. Current work is investigating the screening of formulations as well as particle classification including the analysis of the flow behaviour in microsystems (micro particle image velocimetry).
To generate knowledge in these various fields of application, in addition to process technology (microbioreactors to fermenters, mills, granulators, compression simulators, coaters, etc.), highly sophisticated measuring instruments such as the atomic force microscope (AFM), scanning electron microscope with focused ion beam (SEM-FIB), Raman microscopy, micro computer tomography (µ-CT) and nanoindentation are used in analytics in addition to standard methods. In order to achieve a better understanding, especially of the micro processes, numerical methods such as the discrete elements method (DEM) are also used in all fields of application. Where appropriate and necessary, these are also coupled with fluid dynamic simulations (CFD-DEM).
The team for achieving the research goals in the field of pharma and bioparticle technology at iPAT is as diverse as its tasks: Process engineers work together with biotechnologists, pharmacists and pharmaceutical engineers (graduates of the Master’s programme in Pharmaceutical Engineering).
Fig.: Microsystem for emulsification (left), granulate with active substance nanoparticles (center left), mechanical testing of a tablet (center right), atomic force microscopic images of E. coli (right).