Lean biomanufacturing creating value through innovative bioprocessing approaches
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...
| Autor principal: | |
|---|---|
| Formato: | Libro electrónico |
| Idioma: | Inglés |
| Publicado: |
Oxford :
Woodhead Publishing
2013.
|
| Edición: | 1st edition |
| Colección: | Woodhead Publishing series in biomedicine ;
no. 37. |
| Materias: | |
| Ver en Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009628638906719 |
Tabla de Contenidos:
- Cover; Lean biomanufacturing: Creating value through innovative bioprocessing approaches; Copyright; Contents; Foreword; List of figures; List of tables; Acknowledgements; About the author; 1 An introduction to Lean biomanufacturing; 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
- 1.11 References2 Lean technologies/methods to be applied to biomanufacturing; 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 initiatives2.16 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; 2.23 References; 3 Creation, execution and implementation of the Transition Plan; 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 Management3.6 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; 3.10 References; 4 Issues and problems for the biopharmaceutical industry that make the situation challenging; 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; 4.8 Reference
- 5 Developing a Lean approach to biopharmaceutical processes5.1 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 effi ciently; 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
