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Lean Biomanufacturing

Book Description

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

Table of Contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. Dedication
  6. Foreword
  7. List of figures
  8. List of tables
  9. Acknowledgements
  10. About the author
  11. Chapter 1: An introduction to Lean biomanufacturing
    1. Abstract:
    2. 1.1 What is Lean?
    3. 1.2 Muda, muda, muda – the seven forms of waste
    4. 1.3 Creation of value through the application of Lean
    5. 1.4 SIPOC analysis
    6. 1.5 Flow charting
    7. 1.6 Pull versus push; a change in paradigm for Lean production
    8. 1.7 Benefits of a pull strategy
    9. 1.8 Considering cost issues
    10. 1.9 New approaches to manufacturing
    11. 1.10 The driving force for innovation
  12. Chapter 2: Lean technologies/methods to be applied to biomanufacturing
    1. Abstract:
    2. 2.1 Some key thoughts
    3. 2.2 Box score
    4. 2.3 Some key points
    5. 2.4 Members of the value stream mapping team
    6. 2.5 Where to start?
    7. 2.6 Tools
    8. 2.7 Mapping the process
    9. 2.8 Value stream mapping and identifying waste
    10. 2.9 DMAIC – Define Measure Analyze Improve Control
    11. 2.10 PDCA – Plan Do Check Act
    12. 2.11 Kaizen events/Kaizen blitz
    13. 2.12 Tracing the root cause of waste
    14. 2.13 The 5S tool
    15. 2.14 Transition Plan: translation of the current state to a new state Transition Plan
    16. 2.15 Cultural changes and the importance of change management as a key component of Lean manufacturing/Lean enterprise initiatives
    17. 2.16 Change management and culture transition
    18. 2.17 Cycle time reduction
    19. 2.18 Increasing throughput
    20. 2.19 Process flow implementation and control of variability
    21. 2.20 Control of downtime
    22. 2.21 Pull system implementation
    23. 2.22 Reduction of work in progress
  13. Chapter 3: Creation, execution and implementation of the Transition Plan
    1. Abstract:
    2. 3.1 Background
    3. 3.2 The Analytics Phase
    4. 3.3 Value stream mapping
    5. 3.4 Important tools for implementation of a Transition Plan
    6. 3.5 Change Management
    7. 3.6 Practical Change Management tips and points needed for a successful Transition Process implementation
    8. 3.7 Deployment Phase
    9. 3.8 Evolution of the implementation rollout
    10. 3.9 Summary points
  14. Chapter 4: Issues and problems for the biopharmaceutical industry that make the situation challenging
    1. Abstract:
    2. 4.1 The regulation process
    3. 4.2 Equipment issues
    4. 4.3 Facility issues
    5. 4.4 Upstream/downstream compatibilities
    6. 4.5 Skill sets and manual dexterity
    7. 4.6 Compliance issues
    8. 4.7 Possibilities for product adulteration
  15. Chapter 5: Developing a Lean approach to biopharmaceutical processes
    1. Abstract:
    2. 5.1 Creation of the value stream maps for processes
    3. 5.2 Integration of QC testing laboratories
    4. 5.3 So what are some key considerations?
    5. 5.4 Customer-driven project management (CDPM)
    6. 5.5 Lean laboratory: brief description integration and testing strategies
    7. 5.6 Lean compliance: how quality is maintained efficiently
    8. 5.7 Lean compliance and quality systems
    9. 5.8 Key points for Lean compliance associated with supplier management
    10. 5.9 Developing a Lean product disposition process
    11. 5.10 How to go about removing waste
    12. 5.11 Re-engineering a new approach; creation and implementation of new state
  16. Chapter 6: The contribution of simulation models in the development of Lean biopharmaceutical processes
    1. Abstract:
    2. 6.1 Clinical trial material development and production
    3. 6.2 Commercial scale manufacturing
    4. 6.3 Review of the potential of simulation modeling on Lean manufacturing
    5. 6.4 Important factors for Lean realization in using simulation models
    6. 6.5 Throughput analysis and process bottlenecking
    7. 6.6 Disposable v. conventional system analysis
    8. 6.7 Concluding thoughts
  17. Chapter 7: Integration of biomanufacturing with Lean laboratory operations
    1. Abstract:
    2. 7.1 Use of value stream and process flow mapping techniques to determine best practice
    3. 7.2 Integration of biomanufacturing with Lean laboratory operations
    4. 7.3 Summary of some key points
    5. 7.4 Integration of data management systems to advance analytical efficiency
    6. 7.5 Constraints brought into play by regulatory considerations
    7. 7.6 Concluding thoughts
  18. Chapter 8: Lean compliance and considerations connected with enabling Lean manufacturing
    1. Abstract:
    2. 8.1 Enterprise system approach to quality management
    3. 8.2 Summary
  19. Chapter 9: Ready to use technologies and their role in Lean biomanufacturing
    1. Abstract:
    2. 9.1 Disposables and single-use systems
    3. 9.2 Some advantages and disadvantages of single-use/disposable manufacturing technologies
    4. 9.3 Leachables and extractables
    5. 9.4 Integration of systems
    6. 9.5 Options for smooth flow with disposables approach instead of multiple hold points using conventional technology
    7. 9.6 In summary
    8. 9.7 Concluding thoughts
  20. Appendix
  21. Index