Holger Grohganz
Lektor
E-mail: hgr(at)farma.ku.dk
Telefon: 35 33 64 73
Rum: 13/714

Quality by design (QbD) in the processing of biomacromolecules
The quality by design (QbD) principle can be expected to influence the way of pharmaceutical processing in the years to come towards the development of more rational processes in the production of pharmaceutical formulations. In this project, QbD principles, including process analytical technology (PAT), will be applied on the processing of biomacromolecules.
Freeze-drying and spray-drying are typical methods applied in the stabilization of peptides and proteins. Although those drying methods are widely used, the interaction between various excipients and proteins is not fully understood. This holds especially true, when variations in the processing conditions are taken into account in addition.
It is the aim of the projects to obtain a deeper understanding of the influence of various composition and process parameters on the solid state form of both the excipient and the macromolecule.
The analytical techniques used in this project will include near infra-red spectroscopy, Raman spectroscopy and X-Ray powder diffraction as well as the application of multivariate data analysis.
Supervisor: Holger Grohganz

Implementation of PAT systems in pharmaceutical production processes  (at the University of Ghent, Belgium)
Conventional pharmaceutical manufacturing is generally accomplished using batch processing with off-line time-consuming and less efficient laboratory testing conducted on randomly collected samples to evaluate quality. A first major goal of Process Analytical Technology (PAT) is a better scientific understanding of a manufacturing process to increase process efficiency. One of the most important statements within the PAT concept is that ‘quality should not be tested into products; it should be built in’. The research is focused on the implementation of PAT systems in pharmaceutical production processes of innovative drug dosage forms. Students will have the opportunity to collaborate with PhD students on the following research areas:
- in-line monitoring of critical process and formulation aspects of various pharmaceutical production processes using a wide range process analyzers,
- analysis of the huge data sets obtained from the process analyzers during process monitoring,
- improving knowledge and understanding of processes.
Envisaged pharmaceutical production processes are: freeze-drying, spray processes, hot-melt extrusion and continuous manufacturing (from powder to tablet). All experimental work will be performed at the University of Ghent, Belgium, in the group of Prof. Thomas de Beer.
Supervisors: Holger Grohganz and Thomas de Beer (University of Ghent)