Abstract
BACKGROUND: Downstream processing plays a crucial role in biotechnological production processes. Product concentration and purification require complex, multiβstep operations, using significant amounts of chemical and auxiliary material. Today, design and optimization is important because the process development of biotechnological products is becoming more and more expensive. It is of great importance to improve sustainable development of ecoβefficient products and processes. Integrated process and product development leads to more efficient use of raw materials.
RESULTS: A new stepwise approach is proposed to develop recycling strategies for biopharmaceutical products, which can be implemented within an existing and approved process environment. This article describes the approach in detail and exemplifies the methodical procedure for characteristic reference processes. The theoretical recycling and separation tasks as well as possible strategies are defined and evaluated experimentally. An experimental model parameter determination in small scale is shown. In addition, concrete solutions are discussed due to solving regulatory constraints addressing comparability studies.
CONCLUSION: It is shown that development with the aim of intensification and full integration of the individual steps of bioprocess production (modules, unit operations) leads to an improvement in every single step at the same time. It follows clearly that consistent implementation represents a meaningful contribution to next generation bioproduction design. Copyright Β© 2012 Society of Chemical Industry