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- DescriptionWith decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are w forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful. Following an introduction to lean biomanufacturing, the book goes on to discuss lean techlogies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new techlogy invations which help facilitate lean biomanufacturing.
- Author BiographyNigel J. Smart PhD is a 30 year veteran of the biotechnology industry who has spent his career involved in developing and manufacturing numerous recombinant protein, monoclonal antibody and vaccine products. He holds a BSc from the University of Leicester, and an MSc and PhD in Fermentation Technology/Biochemical Engineeringfrom the University of Manchester. His career has spanned academia, Big Pharma and progressive biotechnology companies involved in cutting-edge biopharmaceutical products. For the last eleven years he has been a much sought-after consultant solving operational problems and compliance related issues to the pharmaceutical and biopharmaceutical industry. This has also included advising the US government on manufacturing strategies to produce a variety of biological countermeasures for the biodefense program. As Managing Partner of Smart Consulting Group, Dr Smart is now a proponent of lean approaches to biopharmaceutical manufacturing processes and leads the company's business team in this area.
- Author(s)Nigel J. Smart
- PublisherElsevier Science & Technology
- Date of Publication01/08/2013
- SubjectIndustrial Chemistry & Manufacturing
- Series TitleWoodhead Publishing Series in Biomedicine
- Series Part/Volume NumberNo. 37
- Place of PublicationCambridge
- Country of PublicationUnited Kingdom
- ImprintWoodhead Publishing Ltd
- Content Noteblack & white illustrations
- Weight710 g
- Width156 mm
- Height234 mm
- Spine22 mm
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