Manufacturing of Pharmaceutical Proteins: From Technology to Economy

by Madjackfrost on October 12, 2009

The present book introduces the basic knowledge of industrial manufacturing of biopharmaceuticals. It is written for those wanting to understand the landscape, interfaces and interactions between the different disciplines relevant for production; as such, aspects of technology and analytics, pharmacy, quality assurance, regulatory affairs, facility technology, and economic efficiency are illustrated.

The work shall serve as textbook and reference at the same time, and is directed towards students as well as industry-experienced engineers, pharmacists, scientists or economists wanting to acquire a basic knowledge of biotechnological production.

Manufacturing advanced drugs under Good Manufacturing Practice conditions can indeed be a critical factor for drug development and marketing. Being part of multidisciplinary teams, it became obvious to me that the technological and economic challenges of biopharmaceutical manufacturing and its interdependencies with adjacent disciplines are not understood everywhere. Decision making in interdisciplinary teams requires communication and appreciation of the constraints on the various counterparts in order to address them efficiently in the overall program. In contrast to this, particular disciplines become more and more specialized, using their language on a level difficult to understand for the counterparts foreign to the field, sometimes flavoring modern project work with a taste of the tale of the Tower of Babel.

Facilitating communication about manufacturing issues is the goal of this book. It does so by using numerous illustrations and simplifications, making the book easy to read. Correlations between disciplines are highlighted by cross-references and a detailed keyword index facilitates the search for special topics. After having read this book, the reader should have a high-level understanding of the roles, correlations between and terminology of the different disciplines engaged in the production of biopharmaceutical proteins. For those wanting to dig deeper into the topics, literature recommendations and weblinks are provided for further reading.

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