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A Practical Guide to Biopharmaceutical Manufacturing
Informa Healthcare, Jan 2006, Pages: 234
Biomanufacturing is an exciting and fundamentally new science that is constantly changing and yielding novel products from emerging technologies. This report A Practical Guide to Biopharmaceutical Manufacturing provides an in-depth understanding of the biopharmaceutical industry. It consists of 10 chapters and highlights the production technologies and operations that occur in the manufacturing facility.
Chapter 1 provides an overview of the biopharmaceutical industry, highlighting the financial and timescale pressures faced during the drug development and manufacturing process, which in part reflect the regulations surrounding the biotechnology industry.
Chapter 2 and 3 are concerned with the production techniques used for the manufacture of a biopharmaceutical.
Chapter 4 describes the process equipment and operations used to support the main production process.
Chapter 5 provides a brief discussion on the design of the biopharmaceutical manufacturing facility, and the monitoring and control methods performed to ensure that the product meets the approved specifications.
Chapter 6 and 7 discuss the benefits and applications of process and cost modelling, present the frameworks used for the modelling and provides examples of the uses of such tools.
Chapter 8 outlines the typical production methods used in the industry to manufacture biotherapeutics by considering sample processes for therapeutics proteins, vaccines, gene therapies and cellular therapies.
Chapter 9 describes the application of the disposable technology, which has a great impact on the operating costs, validation issues and environment concerns in the biopharmaceutical industry.
Finally in chapter 10, the regulatory issues surrounding biopharmaceutical manufacture.
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