Over 80 pages from expert authors providing a mix of practical knowledge and valuable insight to this developing field.
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I am often asked why continuous manufacturing is beneficial to our industry, normally followed up by how the questioner themselves can implement such an improved new platform. There is not one simple answer which suits all inquirers, and so, through a batch-thought process, the concept of this book was inoculated and cultured... continuously.
Of course, perfusion is not new in cell culture, and the ideas of fully continuous processing are not new within the larger biopharmaceutical industry. However the application of these ideas has historically been slow. These ideas have recently taken on significant importance and momentum, perhaps not coincidentally at the same time that technological improvements have made them easier to implement.
The FDA has made several presentations* over the last few years to explain their desire for continuous manufacturing to be more widely applied, and made clear their belief that it enables quality to be directly (and inherently) built into process design - leading to lower risks and lower costs for the industry. Fine in principal, but in practice I am still getting the questions!
Therefore to help me answer those continuous enquiries, this book now exists as a single resource - a first point of reference perhaps - to turn to for those interested. Ten expert authors share their knowledge, experience and vision in a first series of accessible articles. They have been collected together by Refine Technology, but are unedited, with the goal to provide an entry point for your curiosity.
References and further reading suggestions will allow you to dig deeper into the subject of your choice, while all the articles are also available on-line at www.continuous-bioprocessing.com.
The book is inherently a batch medium, whereas the websites will provide additional articles, continuous updates and further resources for the whole bioprocessing community: your starting point for the realization of continuous manufacturing in your own company.
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