Ulteriori informazioni
Informationen zum Autor 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. Klappentext 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. Zusammenfassung 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. Inhaltsverzeichnis 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. ...
Sommario
Dedication
Foreword
List of figures
List of tables
Acknowledgements
About the author
Chapter 1: An introduction to Lean biomanufacturing
Abstract:
1.1 What is Lean?
1.2 Muda, muda, muda - the seven forms of waste
1.3 Creation of value through the application of Lean
1.4 SIPOC analysis
1.5 Flow charting
1.6 Pull versus push; a change in paradigm for Lean production
1.7 Benefits of a pull strategy
1.8 Considering cost issues
1.9 New approaches to manufacturing
1.10 The driving force for innovation
Chapter 2: Lean technologies/methods to be applied to biomanufacturing
Abstract:
2.1 Some key thoughts
2.2 Box score
2.3 Some key points
2.4 Members of the value stream mapping team
2.5 Where to start?
2.6 Tools
2.7 Mapping the process
2.8 Value stream mapping and identifying waste
2.9 DMAIC - Define Measure Analyze Improve Control
2.10 PDCA - Plan Do Check Act
2.11 Kaizen events/Kaizen blitz
2.12 Tracing the root cause of waste
2.13 The 5S tool
2.14 Transition Plan: translation of the current state to a new state Transition Plan
2.15 Cultural changes and the importance of change management as a key component of Lean manufacturing/Lean enterprise initiatives
2.16 Change management and culture transition
2.17 Cycle time reduction
2.18 Increasing throughput
2.19 Process flow implementation and control of variability
2.20 Control of downtime
2.21 Pull system implementation
2.22 Reduction of work in progress
Chapter 3: Creation, execution and implementation of the Transition Plan
Abstract:
3.1 Background
3.2 The Analytics Phase
3.3 Value stream mapping
3.4 Important tools for implementation of a Transition Plan
3.5 Change Management
3.6 Practical Change Management tips and points needed for a successful Transition Process implementation
3.7 Deployment Phase
3.8 Evolution of the implementation rollout
3.9 Summary points
Chapter 4: Issues and problems for the biopharmaceutical industry that make the situation challenging
Abstract:
4.1 The regulation process
4.2 Equipment issues
4.3 Facility issues
4.4 Upstream/downstream compatibilities
4.5 Skill sets and manual dexterity
4.6 Compliance issues
4.7 Possibilities for product adulteration
Chapter 5: Developing a Lean approach to biopharmaceutical processes
Abstract:
5.1 Creation of the value stream maps for processes
5.2 Integration of QC testing laboratories
5.3 So what are some key considerations?
5.4 Customer-driven project management (CDPM)
5.5 Lean laboratory: brief description integration and testing strategies
5.6 Lean compliance: how quality is maintained efficiently
5.7 Lean compliance and quality systems
5.8 Key points for Lean compliance associated with supplier management
5.9 Developing a Lean product disposition process
5.10 How to go about removing waste
5.11 Re-engineering a new approach; creation and implementation of new state
Chapter 6: The contribution of simulation models in the development of Lean biopharmaceutical processes
Abstract:
6.1 Clinical trial material development and production
6.2 Commercial scale manufacturing
6.3 Review of the potential of simulation modeling on Lean manufacturing
6.4 Important factors for Lean realization in using simulation models
6.5 Throughput analysis and process bottlenecking
6.6 Disposable v. conventional system analysis
6.7 Concluding thoughts
Chapter 7: Integration of biomanufacturing with Lean laboratory operations
Abstract:
7.1 Use of valu
