BookMassimo Morbidelli, Moritz Wolf, Jean-Marc Bielser.
Summary: This book is a monography about perfusion cell cultures for the production of biopharmaceuticals, such as therapeutic proteins (i.e. biomolecules like monoclonal antibodies), and describes the fundamentals, design and operation of these processes. Context is given in the first chapters to understand the state-of-the-art of the technology. We then give an overview of the challenges and objectives in operating mammalian cell perfusion cultures and provide guidelines for the design and setup of lab-scale bioreactor systems, and the required control structure to achieve stable operation. Scale-down devices and PAT tools are described in the context of continuous manufacturing and guidelines for process optimization are given using a variety of case studies to illustrate different approaches. Scale-up is also adressed with a strong focus on bioreactor aeration and mixing, shear stress and cell retention device. Finally, a general introduction for the application of mechanistic and statistic models in bioreactor process development and optimization is given in the last chapter. Provided by publisher.
Contents:
Perfusion mammalian cell culture for recombinant protein manufacturing
Perfusion bioreactors : the set up and process characterization
Scale-down models and sensors for process development
Design and optimization of mammalian cell perfusion cultures
Clinical and commercial scale reactors
Mechanistic and statistical modeling of bioprocesses.