Lean Biomanufacturing

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.- A focus on the issues associated with the application of lean principles to biomanufacturing- Practical examples of factors which can affect biopharmaceutical processes- Coverage of key factors which require integration to run an efficient biopharmaceutical process

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 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.

DedicationForewordList of figuresList of tablesAcknowledgementsAbout the authorChapter 1: An introduction to Lean biomanufacturingAbstract:1.1 What is Lean?1.2 Muda, muda, muda - the seven forms of waste1.3 Creation of value through the application of Lean1.4 SIPOC analysis1.5 Flow charting1.6 Pull versus push; a change in paradigm for Lean production1.7 Benefits of a pull strategy1.8 Considering cost issues1.9 New approaches to manufacturing1.10 The driving force for innovationChapter 2: Lean technologies/methods to be applied to biomanufacturingAbstract:2.1 Some key thoughts2.2 Box score2.3 Some key points2.4 Members of the value stream mapping team2.5 Where to start?2.6 Tools2.7 Mapping the process2.8 Value stream mapping and identifying waste2.9 DMAIC - Define Measure Analyze Improve Control2.10 PDCA - Plan Do Check Act2.11 Kaizen events/Kaizen blitz2.12 Tracing the root cause of waste2.13 The 5S tool2.14 Transition Plan: translation of the current state to a new state Transition Plan2.15 Cultural changes and the importance of change management as a key component of Lean manufacturing/Lean enterprise initiatives2.16 Change management and culture transition2.17 Cycle time reduction2.18 Increasing throughput2.19 Process flow implementation and control of variability2.20 Control of downtime2.21 Pull system implementation2.22 Reduction of work in progressChapter 3: Creation, execution and implementation of the Transition PlanAbstract:3.1 Background3.2 The Analytics Phase3.3 Value stream mapping3.4 Important tools for implementation of a Transition Plan3.5 Change Management3.6 Practical Change Management tips and points needed for a successful Transition Process implementation3.7 Deployment Phase3.8 Evolution of the implementation rollout3.9 Summary pointsChapter 4: Issues and problems for the biopharmaceutical industry that make the situation challengingAbstract:4.1 The regulation process4.2 Equipment issues4.3 Facility issues4.4 Upstream/downstream compatibilities4.5 Skill sets and manual dexterity4.6 Compliance issues4.7 Possibilities for product adulterationChapter 5: Developing a Lean approach to biopharmaceutical processesAbstract:5.1 Creation of the value stream maps for processes5.2 Integration of QC testing laboratories5.3 So what are some key considerations?5.4 Customer-driven project management (CDPM)5.5 Lean laboratory: brief description integration and testing strategies5.6 Lean compliance: how quality is maintained efficiently5.7 Lean compliance and quality systems5.8 Key points for Lean compliance associated with supplier management5.9 Developing a Lean product disposition process5.10 How to go about removing waste5.11 Re-engineering a new approach; creation and implementation of new stateChapter 6: The contribution of simulation models in the development of Lean biopharmaceutical processesAbstract:6.1 Clinical trial material development and production6.2 Commercial scale manufacturing6.3 Review of the potential of simulation modeling on Lean manufacturing6.4 Important factors for Lean realization in using simulation models6.5 Throughput analysis and process bottlenecking6.6 Disposable v. conventional system analysis6.7 Concluding thoughtsChapter 7: Integration of biomanufacturing with Lean laboratory operationsAbstract:7.1 Use of value stream and process flow mapping techniques to determine best practice7.2 Integration of biomanufacturing with Lean laboratory operations7.3 Summary of some key points7.4 Integration of data management systems to advance analytical efficiency7.5 Constraints brought into play by regulatory considerations7.6 Concluding thoughtsChapter 8: Lean compliance and considerations connected with enabling Lean manufacturingAbstract:8.1 Enterprise system approach to quality management8.2 SummaryChapter 9: Ready to use technologies and their role in Lean biomanufacturingAbstract:9.