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Quality by Design - the current buzzword in pharmaceutical manufacturing - is based on a detailed understanding of materials, their constitutive behavior and the risks and dynamics of the corresponding production processes. Even more, the ability to monitor and control processes in real time via process analytical technology and advanced model-based control algorithms allows the advent of continuous process improvement, design space concepts and real time release.
Pharmaceutical Engineering Science (PES) is the discipline that focuses on developing the scientific fundamentals for implementing quality by design. Its focus is a rigorous understanding of materials, their interactions and structure, the impact of materials structure and composition on the functionality of the products as well as the complexity of the associated manufacturing processes, reflecting current initiatives of regulatory agencies and policy groups (EMEA, FDA, ICH) and drug manufactures to shift drug development and manufacturing towards a quality-systems based enterprise.
The Graz University of Technology (TUG) of Austria has recently initiated significant efforts in the area of Pharmaceutical Engineering Science. In the summer of 2008 TUG opened a large-scale research center (Research Center for Pharmaceutical Engineering) in cooperation with the University of Graz (KFU), the Austrian Academy of Science (ÖAW) and Joanneum Research (JR). Furthermore, a new Masters course in Pharmaceutical Engineering Science started in the fall of 2008.
The 3rd International Graz Congress for Pharmaceutical Engineering Science is intended to highlight recent developments in the field of drug formulation development and advanced manufacturing both for small-molecule drugs and biopharmaceuticals. The organizing committee would welcome submissions and extends its cordial invitation to Graz in September of 2009. Academic and industrial contributions are welcome.
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