Manufacturing of Pharmaceutical Proteins: From Technology to Economy

Manufacturing of Pharmaceutical Proteins: From Technology to Economy

Volumn , Issue , 2009, Pages 1-390

  Behme, Stefan ^a  

^a NONE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77955222218     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9783527627691     Document Type: Book

References (80)

1. Arvinte, T. (2003) Therapeutical activity predicted and explained by in vitro analytical techniques, in Proceedings of the Conference on Comparability and Immunogenicity of Biologicals, Brussels.
2. Braganz, A. (2001) Seminarunterlagen zu 'Claims Management', Düsseldorf.
3. Brauer, J.-P. (1996) DIN EN ISO 9000-9004 Gestaltungshilfen zum Aufbau Ihres Qualitätsmanagementsystems, Hanser Verlag, Munich.
4. Chmiel, H. (1991) Einf ührung in die Bioverfahrenstechnik, Gustav Fischer Verlag, Stuttgart.
5. Hartmann, K. (2003) Arzneimittelsicherheit, in Jaehde, U., Radziwill, R., Mühlebach, S. and Schunack, W. Lehrbuch der Klinischen Pharmazie, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, pp. 165-183.
6. ISPE (2001) Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 5-Commissioning and Qualification. ISPE, Tampa, FL.
7. Jaehde, U., Radziwill, R., Mühlebach, S. and Schunack, W. (2003) Lehrbuch der Klinischen Pharmazie, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart.
8. Lottspeich, F. and Zorbas, H. (1998) Bioanalytik, Spektrum AkademischerVerlag, Heidelberg.
9. Madigan, M.T., Martinko, J.M., Parker, J., Brock, T.D. and Goebel, W. (eds) (2000) Brock Mikrobiologie, Spektrum Akademischer Verlag, Heidelberg.
10. Olfert, K. (2003) Investition, Kiehl, Ludwigshafen.
11. Plinke, W. and Rese, M. (2002) Industrielle Kostenrechnung, Springer, Berlin.
12. Rautenbach, R. (1997) Membranverfahren, Grundlagen der Modul- und Anlagenauslegung, Springer, Berlin.
13. Schneppe, T. and Müller, R.H. (2003) Qualitätsmanagement und Validierung in der pharmazeutischen Praxis, Editio Cantor, Aulendorf.
14. Stadler, E. (1998) Dual purpose fermenter and bioreactor-a capital quandary? Pharmaceutical Engineering, 18, 74-84.
15. Wheelwright, S.M. (1991) Protein Purification Design and Scale-Up of Downstream Processing, Wiley-Interscience, New York.
16. Borem, A., Santos, F.R. and Bowen, D.E. (2003) Understanding Biotechnology, Prentice Hall, Upper Saddle River, NJ.
17. Dübel, S.(ed.) (2007) Handbook of Therapeutic Antibodies (3 Volumes), Wiley-VCH Verlag GmbH, Weinheim.
18. Gad, S.C.(ed.) (2007) Handbook of Pharmaceutical Biotechnology, John Wiley & Sons, Inc., Hoboken, NJ.
19. Kahl, G. (2004) The Dictionary of Gene Technology: Genomics, Transcriptomics, Proteomics, 3rd edn, Wiley-VCH Verlag GmbH, Weinheim.
20. Schmid, R.D. and Hammelehle, R. (2003) PocketGuide to Biotechnology and Genetic Engineering, Wiley-VCH Verlag GmbH, Weinheim.
21. Walsh, G. (2003) Biopharmaceuticals: Biochemistryand Biotechnology, 2nd edn, John Wiley & Sons, Ltd, Chichester.
22. Walsh, G. (2007) Pharmaceutical Biotechnology: Concepts and Applications, John Wiley & Sons, Ltd, Chichester.
23. Whitford, D. (2005) Proteins: Structure and Function, John Wiley & Sons, Ltd, Chichester.
24. Wiley-VCH (eds) (2007) Ullmann's Biotechnology and Biochemical Engineering (Two Volumes), Wiley-VCH Verlag GmbH, Weinheim.
25. Gelissen, G.(ed.) (2004) Production of Recombinant Proteins: Novel Microbial and Eukaryotic Expression Systems, Wiley-VCH Verlag GmbH, Weinheim.
26. McNeil, B. and Harvey, L.(eds) (2008) PracticalFermentationTechnology, JohnWiley & Sons, Ltd, Chichester.
27. Jornitz, M.W. and Meltzer, T.H. (2007) Filtration and Purification in the Biopharmaceutical Industry, 2nd edn, Informa Healthcare, London.
28. Ladisch, M.R. (2001) Bioseparations Engineering: Principles, Practice, and Economics, John Wiley & Sons, Inc., Hoboken, NJ.
29. Shukla, A.A., Etzel, M.R. and Gadam, S. (2006) Process Scale Bioseparations for the Biopharmaceutical Industry, CRC Press, Boca Raton, FL.
30. Sofer, G. and Hagel, L. (1997) Handbook of Process Chromatography, Academic Press, New York.
31. Zydney, A.L. and Zeman, L.J. (1996) Microfiltration and Ultrafiltration: Principles and Applications, CRC Press, Boca Raton, FL.
32. Banga, A.K. (2005) Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, 2nd edn, CRC Press, Boca Raton, FL.
33. Bontempo, J.A. (1997) Development of Biopharmaceutical Parenteral Dosage Forms, Informa Healthcare, London.
34. Jennnings, T.A.(ed.) (1999) Lyophilization: Introduction and Basic Principles, Informa Healthcare, London.
35. Rey, L. and May, J.C. (2004) Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, 2nd edn, Informa Healthcare, London.
36. Gault, V. (2009) Understanding Bioanalytical Chemistry: Principles and Applications, Wiley-Blackwell, Chichester.
37. Venn, R.F. (2000) Principles and Practice of Bioanalysis, CRCPress, Boca Raton, FL.
38. Berry, I.R. (2004) The Pharmaceutical Regulatory Process, Informa Healthcare, London.
39. Clark, M.E. (2007) Pharmaceutical Law: Regulation of Research, Development, and Marketing, BNA Books, Arlington, VA.
40. Pisano, D.J. and Mantus, D.S. (2008) FDARegulatory Affairs:AGuide for Prescription Drugs, Medical Devices, and Biologics, 2nd edn, Informa Healthcare, London.
41. Siegel, E.B. (ed.) (2008) Development and Approval of Combination Products: A Regulatory Perspective, John Wiley & Sons, Inc., Hoboken, NJ.
42. Bohaychuk, W. and Ball, G. (1999) Conducting GCP-Compliant Clinical Research: A Practical Guide, John Wiley & Sons, Ltd, Chichester.
43. Day, S. (2007) Dictionary for Clinical Trials, 2nd edn, John Wiley & Sons, Ltd, Chichester.
44. Gad, S.C.(ed.) (2008) Preclinical Development Handbook: ADME and Biopharmaceutical Properties, John Wiley & Sons, Inc., Hoboken, NJ.
45. Kelly, W.N. (2006) Pharmacy: What It Is and How It Works, 2nd edn, CRC Press, Boca Raton, FL.
46. Lee, C.-J., Lee, L.H., Wu, C.L., Lee, B.R. and Chen, M.-L. (2005) Clinical Trials of Drugs and Biopharmaceuticals, CRC Press, Boca Raton, FL.
47. Mann, R.D. and Andrews, E.B. (eds) (2007) Pharmacovigilance, 2nd edn, JohnWiley & Sons, Ltd, Chichester.
48. Meibohm, B.(ed.) (2006) Pharmacokinetics and Pharmacodynamics of Biotech Drugs: Principles and Case Studies in Drug Development, Wiley-VCH Verlag GmbH, Weinheim
49. Piantadosi, S. (2005) ClinicalTrials:AMethodologicPerspective, 2ndedn, JohnWiley & Sons, Inc., Hoboken, NJ.
50. Avis, K.E., Wagner, C.M. and Wu, V.L. (1998) Biotechnology: Quality Assurance and Validation, CRC Press, Boca Raton, FL.
51. Bliesner, D.M. (2006) Validating ChromatographicMethods:APracticalGuide, John Wiley & Sons, Inc., Hoboken, NJ.
52. Ermer, J. and Miller, J.H.McB. (2005) MethodValidation in Pharmaceutical Analysis: A Guide to Best Practice, Wiley-VCH Verlag GmbH, Weinheim.
53. Goetsch, D.L.and Davis, S.B. (2001) Understandingand ImplementingISO9000and Other ISO Standards, Prentice Hall, Upper Saddle River, NJ.
54. Goetsch, D.L. and Davis, S.B. (2005) Quality Management, Prentice Hall, Upper Saddle River, NJ.
55. ISPE (2001) Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 5-Commissioning and Qualification. ISPE, Tampa, FL.
56. Nunnally, B.K. and McConnell, J.S. (2007) SixSigma in the Pharmaceutical Industry: Understanding, Reducing and Controlling Variation in Pharmaceuticals and Biologics, CRC Press, Boca Raton, FL.
57. Prichard, E. and Barwick, V. (2007) Quality Assurance in Analytical Chemistry, John Wiley & Sons, Ltd, Chichester.
58. Sarker, D.K. (2008) Quality Systems and Controls for Pharmaceuticals John Wiley & Sons, Ltd, Chichester.
59. Haider, S.I. (2001) Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance, Informa Healthcare, London.
60. Miller, J.M. and Crowther, J.B.(eds) (2000) Analytical Chemistry in a GMP Environment: A Practical Guide, John Wiley & Sons, Inc., Hoboken, NJ.
61. Nally, J.(ed.) (2006) Good Manufacturing Practices for Pharmaceuticals, Sixth edn, Informa Healthcare, London.
62. Sharp, J. (2004) Good Pharmaceutical Manufacturing Practice: Rationale and Compliance, Informa Healthcare, London.
63. ISPE (1999) Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 3-Sterile Manufacturing Facilities. ISPE, Tampa, FL
64. ISPE (2001) Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 4-Water and Steam Systems. ISPE, Tampa, FL
65. ISPE (2004) Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities, Vol. 6-Biopharmaceuticals. ISPE, Tampa, FL
66. Odum, J.N. (2004) Sterile Product Facility Design and ProjectManagement, 2nd edn, CRC Press, Boca Raton, FL.
67. Dixon, A.M. (2006) Environmental Monitoring for Cleanrooms and Controlled Environments, Informa Healthcare, London.
68. Seiberling, D.A. (2007) Clean-in-Place for Biopharmaceutical Process, Informa Healthcare, London.
69. Whyte, W.(ed.) (1999) Cleanroom Design, 2nd edn, John Wiley & Sons, Ltd, Chichester.
70. Whyte, W. (2001) Cleanroom Technology: Fundamentals of Design, Testing and Operation, John Wiley & Sons, Ltd, Chichester.
71. Frame, J.D. (2003) Managing Projects in Organizations: How toMake the Best Use of Time, Techniques, and People, 3rd edn, Jossey Bass, San Francisco, CA.
72. Kerzner, H. (2006) ProjectManagement:ASystemsApproach to Planning, Scheduling, and Controlling, 9th edn, John Wiley & Sons, Inc., Hoboken, NJ.
73. Clark, F. and Lorenzoni, A.B. (1996) Applied Cost Engineering, 3rd edn, CRCPress, Boca Raton, FL.
74. Kleinfeld, I.H. (1992) Engineering Economics Analysis for Evaluation of Alternatives, John Wiley & Sons, Inc., Hoboken, NJ.
75. Simonsen, C.B. and Shaw, S. (2006) Essentials of Environmental Law, PrenticeHall, Upper Saddle River, NJ.
76. Stewart, R.D., Wyskida, R.M. and Johannes, J.D.(eds) (1995) Cost Estimator's Reference Manual, 2nd edn, John Wiley & Sons, Inc., Hoboken, NJ.
77. Bozarth, C. and Handfield, R.B. (2007) Introduction to Operations and Supply Chain Management, Prentice Hall, Upper Saddle River, NJ.
78. Epstein, A. (2008) Contract Law Fundamentals, Prentice Hall, UpperSaddleRiver, NJ.
79. Hartman, J.C. (2006) Engineering Economy and the Decision-Making Process, Prentice Hall, Upper Saddle River, NJ.
80. Kimmel, P.D., Weygandt, J.J. and Kieso, D.E. (2006) Financial Accounting: Tools for Business Decision Making, Working Papers, 4th edn, John Wiley & Sons, Inc., Hoboken, NJ.