Linköping University - Articles and news items

PAT and design science

Issue 3 2007 / 23 May 2007 / Carl-Fredrik Mandenius, Micael Derelöv, Jonas Detterfelt, Mats Björkman, Division of Biotechnology/IFM and Division of Production Systems/IKP, Linköping University, Sweden

Process analytical technology (PAT) and mechanical design science are interconnected; this article describes how a well-established design modelling approach; the Hubka-Eder model, is applied to the concepts of PAT and quality by design (QBD). The model connects PAT with quality management concepts as defined for PAT by the ICH guidelines for quality issues. Examples are taken from biopharmaceutical applications, but these are also applicable to other active pharmaceutical ingredients (API). Benefits of using a conceptual design modelling approach in PAT and related subjects are discussed and suggested as a complementary functionality analysis tool in PAT and quality design of pharmaceutical processes.

The role of PAT in biotechnology

Issue 3 2006, Past issues / 23 May 2006 / Carl-Fredrik Mandenius, Linköping University, Sweden, Member of the European Federation for Pharmaceutical Sciences PAT Steering Group

Product quality of pharmaceuticals manufactured in biotechnology processes is to a large extent synonymous with the reduction and control of unwanted biological side-products. Production of biopharmaceutical proteins and secondary metabolites such as antibiotics are the result of biosynthetic capacity of the microbes or cells used. But this capacity may also contribute to turn the product […]


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