Advances in Large Scale BioManufacturing and Scale-Up Production, 2nd Edition
A Comprehensive Study of the Science, Technology and Business of Biopharmaceutical Manufacturing.

Published by the ASM Press [American Society for Microbiology Press] and BioPlan Associates, Inc., November 2007.

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Chapter Abstracts Index:

1. Frontiers in Bioprocessing: 2007
2. The Science for Biogenerics: Are We There Already?
3. Maximizing Productivity in Biopharmaceutical Manufacturing
4. Increasing Performance of Mammalian Expression Platforms
5. Cell Line Engineering and Development: Case Studies
6. Design of Large-Scale Cell Culture Process
7. Challenges in Biopharmaceutical Scale-up to Production
8. Large-Scale Microbial Production Technology for Human Therapeutic Products
9. Microbiological Methods in Support of Manufacturing
10. Initial Protein Recovery Process
11. The Scaling Up of Fermentation and Primary Recovery Processes of Soluble Protein Antigens
12. Scale-up of Saccharomyces cerevisiae Fermentation
13. Good Automation Manufacturing Practice (GAMP)
14. Advances in Improved Expression of Recombinant Proteins in Microbial Systems
15. Design of Large-Scale Cell Culture Process —A Process Engineering Point of View
16. Protein Stability, Solubility and Solute Interactions
17. Launching New Biologics: A Process and Facility Design Approach
18. Disposable Technologies for Manufacturing of Biologics
19. Managing Large Volume, Single Use Disposables
20. Optimization of Antibody Processing: Upstream and Downstream
21. Simulated Moving Bed Chromatography
22. Implementation of Membrane Technology in Antibody Large-Scale Purification
23. Development of Viral Clearance Strategies for Large-Scale Monoclonal Antibody Production
24. Downstream Processing: Removing Economic and Technical Bottlenecks
25. Purification of Monoclonal and Genetically Engineered Antibodies
26. Regulatory Environment for Follow-on Biologics
27. Post-Approval Changes for Large Scale Biopharmaceutical Manufacturing: Global
28. FDA and Regulatory Issues in Biopharmaceutical Manufacturing
29. Strategic Issues: Capital Investments
30. Pricing Issues for Biotechnology Products
31. Economics of Scheduling, De-bottlenecking, and Cycle Time
32. Intellectual Property Considerations in Scale-Up of Biomanufacturing Processes
33. Forecasting Industry-wide Biopharmaceutical Manufacturing Capacity Requirements
34. Worldwide Therapeutic Protein Production Capacity

Authors and Reviewers:

1. Accelsiors Group International
2. Advanced Scientifics Inc.
3. Amgen, Inc.
4. Amgen, Inc.
5. Amgen, Inc.
6. Amgen, Inc.
7. Amgen, Inc.
8. Biogen IDEC
9. Biomanufacturing Training and Education Center
10. BioPharm Services UK
11. BioProcess Technology
12. Biotechnology Unit, NIDDK, NIH
13. Bristol Myers Squibb
14. Chromos, Burnaby, BC
15. Cambrex Bio Science
16. Clonex Development, Inc.
17. Consultants Inc.
18. Eli Lilly & Co.
19. Eli Lilly & Co.
20. Eli Lilly & Co.
21. Eli Lilly & Co.
22. Excellent Pharma Consulting
23. Falconridge Associates
24. Fluor Corporation/Fluor Daniel Inc.
25. Fluor Corporation/Fluor Daniel Inc.
26. Fluor Corporation/Fluor Daniel Inc.
27. GE Healthcare
28. Human Genome Sciences
29. Institute for Chemical and Bioengineering
30. Intelligen, Inc.
31. Johns Hopkins University
32. Magneticals
33. Max Planck Institute
34. Medical Marketing Economics, LLC
35. Medimmune
36. Merck & Co., Inc.
37. Merck Research Laboratories
38. Merck Research Laboratories
39. Morphotek
40. NC State University
41. ncBIOsource
42. Newport Biotech Consultants
43. Newport Consulting
44. Novavax Inc
45. Novozymes Delta Limited
46. PD-Direct Services
47. Protein Sciences Corp
48. SAIC, National Cancer Institute
49. Sanofi Pasteur
50. Sartorius AG, Germany
51. Schwegman Lundberg Woessner & Kluth
52. Scios Inc.
53. Seattle Genetics
54. Strategic Manufacturing Worldwide, Inc.
55. TLG Consulting Inc.
56. Université Clermont
57. Vectech Pharmaceutical Consultants, Inc.