Lean Biomanufacturing: Creating Value Through Innovative Bioprocessing Approaches

Summary: With 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 now 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 technologies 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 technology innovations which help facilitate lean biomanufacturing. About the author: Nigel 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 Engineering from 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. Contents: An introduction to Lean biomanufacturing; Lean technologies/methods to be applied to biomanufacturing; Creation, execution and implementation of the Transition Plan; Issues and problems for the biopharmaceutical industry that make the situation challenging; Developing a Lean approach to biopharmaceutical processes; The contribution of simulation models in the development of Lean biopharmaceutical processes; Integration of biomanufacturing with Lean laboratory operations; Lean compliance and considerations connected with enabling Lean manufacturing; Ready to use technologies and their role in Lean biomanufacturing