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.
Related posts:
- Good Pharmaceutical Manufacturing Practice Rationale and Compliance
- Pharmaceutical Manufacturing Handbook: Regulations and Quality
- Pharmaceutical Suspensions : From Formulation Development to Manufacturing
- Australian code of good manufacturing practice for medicinal products
- A WHO guide to good manufacturing practice (GMP) requirements
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