Bioprocess manufacturing tool preview
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With the biotechnology industry in the early phases of commercialization, many bioprocess companies are just beginning to build and operate commercial-scale production facilities. The commercialization of manufacturing processes has brought new challenges to the biotechnology industry. Designing, constructing, and operating production facilities are particularly challenging to an industry previously focused predominantly on researching and developing new products. Biopharmaceutical companies need guidance to make the transition to commercial scale biotechnology production. ISPE, the Society for Life Science Professionals, provides such guidance with its insight into the design and operation of bioprocess manufacturing. Over the past several years, ISPE has developed a series of pharmaceutical industry guides that describe engineering and operational principles of various types of pharmaceutical manufacturing and support systems. The ISPE Baseline Pharmaceutical Engineering Guides are invaluable to industry, but none of them will have more impact than the soon-to-be-released sixth volume, which covers biopharmaceuticals. Commercial manufacturing of biopharmaceutical products is still rapidly developing. Likewise, understanding of the processes and systems being designed is still evolving. At this point in biotechnology’s evolution, there is a rapidly growing need for qualified people. The Biopharmaceuticals Baseline Guide provides insight from a variety of biotechnology industry experts. The guide, developed in cooperation with FDA, is specifically written to simplify complex concepts and highlight aspects critical to successful bioprocess operations. It is an excellent educational tool, covering subject matter of great importance to bioprocess manufacturers, regardless of their expertise or experience. This guide will help manufacturers focus on the issues that are most important to their ultimate success and give them more confidence in the approach they choose. Spending on noncritical components will be reduced. Ultimately, appropriate, simpler, less expensive, and easier to operate systems will be installed. The result will not only cut capital costs, but it also will reduce operating costs while improving or assuring product quality. THE GUIDE IN BRIEF The Biopharmaceuticals Baseline Guide, the newest volume in the ISPE Baseline Guide series, addresses aspects of biopharmaceutical manufacturing ranging from operations to facility and process designs to regulatory concepts. Although it’s not a textbook, it provides substantial insight into key Source : accessmylibrary.com |