-
1
-
-
34548324706
-
The cost of biopharmaceutical R&D: is biotech different? Manage
-
DiMasi, J.A. and Grabowski, H.G. (2007) The cost of biopharmaceutical R&D: is biotech different? Manage. Decis. Econ., 28, 469-479.
-
(2007)
Decis. Econ.
, vol.28
, pp. 469-479
-
-
DiMasi, J.A.1
Grabowski, H.G.2
-
2
-
-
84885531110
-
Harris Interactive: poll conducted online by between April 30 and May 14 2008
-
[2008(] Harris Interactive: poll conducted online by between April 30 and May 14 2008, published by International Herald Tribune, May
-
(2008)
published by International Herald Tribune, May
-
-
-
4
-
-
84889966052
-
Current status of modern biopharmaceuticals: Approved products and trends in approvals, in Modern Biopharmaceuticals
-
Walsh, G. (2005) Current status of modern biopharmaceuticals: Approved products and trends in approvals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1 (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1-34.
-
(2005)
Design, Development and Optimization 1ed.J.KnableinWiley-VCHVerlagGmbH
, pp. 1-34
-
-
Walsh, G.1
-
5
-
-
84889979454
-
Manufacture of recombinant Biopharmaceuticals, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Wurm, F. (2005) Manufacture of recombinant Biopharmaceuticals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 723-759.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 723-759
-
-
Wurm, F.1
-
6
-
-
84889998891
-
Advanced expression of biopharmaceuticals at industrial scale: the insulin success story, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Andersen, A.S. and Diers, I. (2005) Advanced expression of biopharmaceuticals at industrial scale: the insulin success story, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1033-1042.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1033-1042
-
-
Andersen, A.S.1
Diers, I.2
-
7
-
-
84885548343
-
Healthcare trends and their impact on the biopharmaceutical industry: biopharmaceuticals come of age, in Modern Biopharmaceuticals
-
part VIII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p
-
Moscho, A., Schafer, M. A., and Yarema, K. (2005) Healthcare trends and their impact on the biopharmaceutical industry: biopharmaceuticals come of age, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VIII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1711-1739.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1711-1739
-
-
Moscho, A.1
Schafer, M.A.2
Yarema, K.3
-
8
-
-
84889960726
-
The development of Herceptin1: paving the way for individualized cancer therapy, in Modern Biopharmaceuticals
-
part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p
-
Gutjahr, T. (2005) The development of Herceptin1: paving the way for individualized cancer therapy, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 127-149.
-
(2005)
Design, Development and Optimization
, vol.1
, pp. 127-149
-
-
Gutjahr, T.1
-
9
-
-
84890004131
-
Contract manufacturing of biopharmaceuticals including antibodies or antibody fragments, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Hempel, J.C. et al. (2005) Contract manufacturing of biopharmaceuticals including antibodies or antibody fragments, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1083-1142.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1083-1142
-
-
Hempel, J.C.1
-
10
-
-
84890004632
-
Modern antibody technology: the impact on drug development, in Modern Biopharmaceuticals
-
part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Moroney, S. and Pluckthun, A. (2005) Modern antibody technology: the impact on drug development, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1147-1186.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1147-1186
-
-
Moroney, S.1
Pluckthun, A.2
-
11
-
-
84889995203
-
Thirty years of monoclonal antibodies: a long way to pharmaceutical and commercial success, in Modern Biopharmaceuticals
-
part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Gottschalk, U. and Mundt, K. (2005) Thirty years of monoclonal antibodies: a long way to pharmaceutical and commercial success, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1105-1145.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1105-1145
-
-
Gottschalk, U.1
Mundt, K.2
-
12
-
-
84885534597
-
AIDS gene therapy: a vector selectively able to destroy latently HIV-1-infectedCells, in Modern Biopharmaceuticals
-
part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
V́azquez, F.L. and Oya, R. (2005) AIDS gene therapy: a vector selectively able to destroy latently HIV-1-infectedCells, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 549-559.
-
(2005)
Design, Development and Optimization
, vol.2
, pp. 549-559
-
-
Vázquez, F.L.1
Oya, R.2
-
13
-
-
84889983969
-
Rational siRNA design for RNA interference: optimization for therapeutic use, in Modern Biopharmaceuticals
-
part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Boese, Q. and Khvorova, A., (2005) Rational siRNA design for RNA interference: optimization for therapeutic use, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 243-264.
-
(2005)
Design, Development and Optimization
, vol.1
, pp. 243-264
-
-
Boese, Q.1
Khvorova, A.2
-
14
-
-
84889964545
-
Combinatorial RNA-based Therapies for HIV-1, in Modern Biopharmaceuticals
-
part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Morris, K.V. and Rossi, J.J. (2005) Combinatorial RNA-based Therapies for HIV-1, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 569-577.
-
(2005)
Design, Development and Optimization
, vol.2
, pp. 569-577
-
-
Morris, K.V.1
Rossi, J.J.2
-
15
-
-
34247170389
-
Programmed packaging: a new drug delivery system and its application to Gene therapy, in Modern Biopharmaceuticals
-
part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Kogure, K., Akita, H., Kamiya, H., and Harashima, H. (2005) Programmed packaging: a new drug delivery system and its application to Gene therapy, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1521-1534.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1521-1534
-
-
Kogure, K.1
Akita, H.2
Kamiya, H.3
Harashima, H.4
-
16
-
-
84889954515
-
Novel vaccine adjuvants based on cationic peptide delivery systems, in Modern Biopharmaceuticals
-
part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Lingnau, K., Klade, C., Buschle, M., and von Gabain, A. (2005) Novel vaccine adjuvants based on cationic peptide delivery systems, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1419- 1440.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1419-1440
-
-
Lingnau, K.1
Klade, C.2
Buschle, M.3
von Gabain, A.4
-
17
-
-
84889986358
-
Ligand-based targeting of disease: From antibodies to small organic (synthetic) ligands, in Modern Biopharmaceuticals
-
part V (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Silacci, M. and Neri, D. (2005) Ligand-based targeting of disease: From antibodies to small organic (synthetic) ligands, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part V (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1271-1289.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1271-1289
-
-
Silacci, M.1
Neri, D.2
-
18
-
-
84889958217
-
Spheramine1: a cell therapeutic approach to Parkinson's disease, in Modern Biopharmaceuticals
-
part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Reissig, E., Graf, H., and Kapp, F.-J., (2005) Spheramine1: a cell therapeutic approach to Parkinson's disease, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 1, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 325-348.
-
(2005)
Design, Development and Optimization
, vol.1
, pp. 325-348
-
-
Reissig, E.1
Graf, H.2
Kapp, F.J.3
-
19
-
-
84885543977
-
The evolving role of oral spray insulin in the treatment of diabetes, in Modern Biopharmaceuticals
-
part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Modi, P., (2005) The evolving role of oral spray insulin in the treatment of diabetes, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VI (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1445-1460.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1445-1460
-
-
Modi, P.1
-
21
-
-
84885556808
-
Chapter 8 Process Economy in Handbook of Process Chromatography
-
Hagel, L., Jagschies, G., and Sofer, G. (2007) Chapter 8: Process Economy in Handbook of Process Chromatography, 2nd edn, Elsevier Academic Press, pp. 189-218.
-
(2007)
2nd edn, Elsevier Academic Press
, pp. 189-218
-
-
Hagel, L.1
Jagschies, G.2
Sofer, G.3
-
23
-
-
84885518037
-
IBM Global Business Services Pharma The Threshold of Innovation, Somers, NY
-
2004 from (accessed 27 December, 2012)
-
IBM Global Business Services Pharma 2010, The Threshold of Innovation, Somers, NY, 2004 from http://www-935.ibm.com/services/de/bcs/pdf/2006/pharma_2010.pdf (accessed 27 December, 2012).
-
(2010)
-
-
-
24
-
-
57749086529
-
Consideration for developing biopharmaceuticals: FDA perspective, in Modern Biopharmaceuticals
-
part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Brorson, K. et al. (2005) Consideration for developing biopharmaceuticals: FDA perspective, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1637- 1667.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1637-1667
-
-
Brorson, K.1
-
25
-
-
84889956486
-
The regulatory environment for biopharmaceuticals in the EU, in Modern Biopharmaceuticals
-
part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Wenzel, A.F. and Sonnega, C.E.A. (2005) The regulatory environment for biopharmaceuticals in the EU, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 4, part VII (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1669- 1701.
-
(2005)
Design, Development and Optimization
, vol.4
, pp. 1669-1701
-
-
Wenzel, A.F.1
Sonnega, C.E.A.2
-
26
-
-
84889970670
-
Large-scale detection of genetic variation: the key to personalized medicine, in Modern Biopharmaceuticals
-
part I (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Geistlinger, J. and Ahnert, P. (2005) Large-scale detection of genetic variation: the key to personalized medicine, in Modern Biopharmaceuticals - Design, Development and Optimization, part I (ed. J. Knablein), Wiley-VCH Verlag GmbH, vol. 1, p. 71-93.
-
(2005)
Design, Development and Optimization
, vol.1
, pp. 71-93
-
-
Geistlinger, J.1
Ahnert, P.2
-
27
-
-
84885536813
-
The role of pharmacogenetics and pharmacongenomics, Modern Biop ha rmaceuticals De s i gn, D ev e lo p me n t a nd Optimization
-
part I (ed. J. Knablein) Wi le y-V CH Ve r la g G mbH
-
Huang, S .-M. an d Les ko, L. (2 005) The role of pharmacogenetics and pharmacongenomics, Modern Biop ha rmaceuticals - De s i gn, D ev e lo p me n t a nd Optimization, vol. 1, part I (ed. J. Knablein), Wi le y-V CH Ve r la g G mbH, p. 50-64.
-
(2005)
, vol.1
, pp. 50-64
-
-
Huang, S.M.1
Les ko, L.2
-
31
-
-
84885515865
-
US FDA Guidance for Industry
-
May
-
US FDA (2006) Guidance for Industry, Q8 Pharmaceutical Development, May
-
(2006)
Q8 Pharmaceutical Development
-
-
-
33
-
-
34247474373
-
Quality: design space for biotech products
-
Rathore, A.S., Branning, R., and Cecchini, D. (2007) Quality: design space for biotech products. BioPharm, 20 (4).
-
(2007)
BioPharm
, vol.20
, Issue.4
-
-
Rathore, A.S.1
Branning, R.2
Cecchini, D.3
-
34
-
-
46249092863
-
High-throughput screening of chromatographic separations: I. method development and column modeling
-
Coffman, J.L., Kramarczyk, J.F., and Kelley, B.D. (2008) High-throughput screening of chromatographic separations: I. method development and column modeling. Biotechnol. Bioeng., 100 (4), 605-618.
-
(2008)
Biotechnol. Bioeng.
, vol.100
, Issue.4
, pp. 605-618
-
-
Coffman, J.L.1
Kramarczyk, J.F.2
Kelley, B.D.3
-
35
-
-
46249100489
-
High-throughput screening of chromatographic separations: IV
-
Kelley, B.D., Switzer, M., Bastek, P., Kramarczyk, J.F., Molnar, K., Yu, T., and Coffman, J. (2008) High-throughput screening of chromatographic separations: IV. Ion-exchange. Biotechnol. Bioeng., 100 (5), 950-963.
-
(2008)
Ion-exchange. Biotechnol. Bioeng.
, vol.100
, Issue.5
, pp. 950-963
-
-
Kelley, B.D.1
Switzer, M.2
Bastek, P.3
Kramarczyk, J.F.4
Molnar, K.5
Yu, T.6
Coffman, J.7
-
36
-
-
84885520936
-
Utilizing an advanced high-throughput microbioreactor experimentation system. Presented at PDA
-
San Diego CA, January 2007
-
Stokelman, A. (2007) Utilizing an advanced high-throughput microbioreactor experimentation system. Presented at PDA: Emerging Manufacturing and Quality Control Technologies, San Diego CA, January 2007.
-
(2007)
Emerging Manufacturing and Quality Control Technologies
-
-
Stokelman, A.1
-
37
-
-
84885504977
-
Chapter 2 Process capability in Handbook of Process Chromatography
-
Hagel, L., Jagschies, G., and Sofer, G. (2007) Chapter 2: Process capability in Handbook of Process Chromatography, 2nd edn, Elsevier Academic Press, pp. 23-39.
-
(2007)
2nd edn, Elsevier Academic Press
, pp. 23-39
-
-
Hagel, L.1
Jagschies, G.2
Sofer, G.3
-
38
-
-
84885537286
-
Impact and benefits of applying QbD in cell line development to downstream process development
-
Boston MA, October 1
-
Reddy, P. (2007) Impact and benefits of applying QbD in cell line development to downstream process development. Presented at IBC Bioprocess International, Boston MA, October 1.
-
(2007)
Presented at IBC Bioprocess International
-
-
Reddy, P.1
-
39
-
-
84885540505
-
A new technology standard for safety and efficacy in factor VIII replacement therapy: designing an advanced category rFVIII concentrate, in Modern Biopharmaceuticals
-
part II (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Riedel, N. and Dorner, F. (2005) A new technology standard for safety and efficacy in factor VIII replacement therapy: designing an advanced category rFVIII concentrate, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 2, part II (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 419-447.
-
(2005)
Design, Development and Optimization
, vol.2
, pp. 419-447
-
-
Riedel, N.1
Dorner, F.2
-
40
-
-
77956945657
-
Alternative strategies and new cell lines for high-level production of biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH VerlagGmbH
-
Rose, T.,Winkler, K., Brundke, E., et al. (2005) Alternative strategies and new cell lines for high-level production of biopharmaceuticals, in Modern Biopharmaceuticals - Design,Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH VerlagGmbH, p. 761-776.
-
(2005)
in Modern Biopharmaceuticals Design,Development and Optimization
, vol.3
, pp. 761-776
-
-
Rose, T.1
Winkler, K.2
Brundke, E.3
-
41
-
-
84885496928
-
PER. C61 cells for the manufacture of biopharmaceutical proteins, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Yallop, C., Crowley, J., Cote, J., Hegmans-Brouwer, K., Lagerwerf, F., Gagne, R., Martin, J.C., Oosterhuis, N., Opstelten, D.-J., and Bout, A. (2005) PER. C61 cells for the manufacture of biopharmaceutical proteins, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 780-803.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 780-803
-
-
Yallop, C.1
Crowley, J.2
Cote, J.3
Hegmans-Brouwer, K.4
Lagerwerf, F.5
Gagne, R.6
Martin, J.C.7
Oosterhuis, N.8
Opstelten, D.J.9
Bout, A.10
-
42
-
-
84889996874
-
Use of the glutamine synthetase (GS) expression system for the rapid development of highly productive mammalian cell processes, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Birch, J.R., Mainwaring, D.O., and Racher, A.J., Use of the glutamine synthetase (GS) expression system for the rapid development of highly productive mammalian cell processes, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 809-830.
-
Design, Development and Optimization
, vol.3
, pp. 809-830
-
-
Birch, J.R.1
Mainwaring, D.O.2
Racher, A.J.3
-
43
-
-
84885513817
-
Platform facility fit issues for high titer processes
-
Anaheim, CA, September 26
-
Trexler-Schmidt, M. (2008) Platform facility fit issues for high titer processes. Presented at IBC Bioprocess International, Anaheim, CA, September 26.
-
(2008)
Presented at IBC Bioprocess International
-
-
Trexler-Schmidt, M.1
-
44
-
-
84885524979
-
Reconfiguration of a commercial biologics facility to a launch facility for new product introductions: balancing process and engineering solutions
-
Anaheim, CA, Septermber 26
-
Gadam, S. (2008) Reconfiguration of a commercial biologics facility to a launch facility for new product introductions: balancing process and engineering solutions. Presented at IBC Bioprocess International, Anaheim, CA, Septermber 26.
-
(2008)
Presented at IBC Bioprocess International
-
-
Gadam, S.1
-
45
-
-
35348866110
-
Very large scale monoclonal antibody purification: the case for conventional unit operations
-
Kelley, B. (2007) Very large scale monoclonal antibody purification: the case for conventional unit operations. Biotechnol. Prog., 23, 995-1008.
-
(2007)
Biotechnol. Prog.
, vol.23
, pp. 995-1008
-
-
Kelley, B.1
-
46
-
-
84889956145
-
Producing modern biopharmaceuticals, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Apeler, H. (2005) Producing modern biopharmaceuticals, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 1021-1031.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 1021-1031
-
-
Apeler, H.1
-
47
-
-
84889958106
-
Humanized glycosylation: production of biopharmaceuticals in a moss bioreactor, in Modern Biopharmaceuticals
-
part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH
-
Gorr, G. and Wagner, S. (2005) Humanized glycosylation: production of biopharmaceuticals in a moss bioreactor, in Modern Biopharmaceuticals - Design, Development and Optimization, vol. 3, part IV (ed. J. Knablein), Wiley-VCH Verlag GmbH, p. 919-927.
-
(2005)
Design, Development and Optimization
, vol.3
, pp. 919-927
-
-
Gorr, G.1
Wagner, S.2
-
48
-
-
84885557674
-
Technology development for purification of 1g/L/day antibody processes
-
XIII, Quebec City, Canada, June 24
-
Coffman, J.L., Bolton, G., Gallo, C., Tobler, S., and Godavarti, R. (2008) Technology development for purification of 1g/L/day antibody processes. Presented at Recovery of Biological Products, XIII, Quebec City, Canada, June 24.
-
(2008)
Presented at Recovery of Biological Products
-
-
Coffman, J.L.1
Bolton, G.2
Gallo, C.3
Tobler, S.4
Godavarti, R.5
-
50
-
-
33749236399
-
Established bioprocesses for producing antibodies as a basis for future planning. Adv. Biochem
-
Engin/Biotechnol., Springer Verlag Berlin, Heidelberg, published online 8 June
-
Farid, S.S. (2006) Established bioprocesses for producing antibodies as a basis for future planning. Adv. Biochem. Engin/Biotechnol., Springer Verlag Berlin, Heidelberg, published online 8 June.
-
(2006)
-
-
Farid, S.S.1
|