-
1
-
-
79953673689
-
-
U.S. Department of Health and Human Services, Food and Drug Administration: Guidance for industry: PAT - a framework for innovative pharmaceutical development, manufacturing and quality assurance, Accessed 01/10/10.
-
U.S. Department of Health and Human Services, Food and Drug Administration: Guidance for industry: PAT - a framework for innovative pharmaceutical development, manufacturing and quality assurance http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf, Accessed 01/10/10.
-
-
-
-
2
-
-
77955984086
-
Process analytical technology (PAT) for biopharmaceutical products.
-
Rathore, A. S., Bhambure, R., Ghare, V., Process analytical technology (PAT) for biopharmaceutical products. Anal. Bioanal. Chem. 2010, 398, 137-154.
-
(2010)
Anal. Bioanal. Chem.
, vol.398
, pp. 137-154
-
-
Rathore, A.S.1
Bhambure, R.2
Ghare, V.3
-
3
-
-
79953726115
-
-
(Ed.), Process analytical technology. Blackwell Publishing, Oxford.
-
Bakeev, K. A. (Ed.), Process analytical technology. Blackwell Publishing, Oxford 2005.
-
(2005)
-
-
Bakeev, K.A.1
-
4
-
-
84889466137
-
-
(Eds.), Quality by design for biopharmaceuticals: principles and case studies. Wiley and Sons Inc, New York.
-
Rathore, A. S., Mhatre, R. (Eds.), Quality by design for biopharmaceuticals: principles and case studies. Wiley and Sons Inc, New York 2009.
-
(2009)
-
-
Rathore, A.S.1
Mhatre, R.2
-
5
-
-
79953725531
-
Quality-by-Design (QbD) for biotechnology-related phamaceuticals.
-
Mandenius, C. F., Graumann, K., Schultz, T. W., Premsteller, A. et al., Quality-by-Design (QbD) for biotechnology-related phamaceuticals. Biotechnol. J. 2009, 4, 11-20.
-
(2009)
Biotechnol. J.
, vol.4
, pp. 11-20
-
-
Mandenius, C.F.1
Graumann, K.2
Schultz, T.W.3
Premsteller, A.4
-
6
-
-
0036080082
-
Multivariate methods in pharmaceutical applications.
-
Gabrielsson, J., Lindberg, N.-O., Lundstedt, T., Multivariate methods in pharmaceutical applications. J. Chemometrics 2002, 16, 141-160.
-
(2002)
J. Chemometrics
, vol.16
, pp. 141-160
-
-
Gabrielsson, J.1
Lindberg, N.-O.2
Lundstedt, T.3
-
7
-
-
33644686538
-
The process analytical tehcnology initiative and multivariate process analysis, monitoring and control.
-
Kourti, T., The process analytical tehcnology initiative and multivariate process analysis, monitoring and control. Anal. Bioanal. Chem. 2006, 384, 1043-1048.
-
(2006)
Anal. Bioanal. Chem.
, vol.384
, pp. 1043-1048
-
-
Kourti, T.1
-
8
-
-
0037073192
-
Enhanced bio-manufacturing through advanced multivariate statistical technologies.
-
Martin, E. B., Morris, A. J., Enhanced bio-manufacturing through advanced multivariate statistical technologies. J. Biotechnol. 2002, 99, 223-235.
-
(2002)
J. Biotechnol.
, vol.99
, pp. 223-235
-
-
Martin, E.B.1
Morris, A.J.2
-
9
-
-
0037142415
-
An assessment of seed quality and its influence on productivity estimation in an industrial antibiotic fermentation.
-
Cunha, C. C. F., Glassey, J., Montague, G. A., Albert, S., Mohan, P., An assessment of seed quality and its influence on productivity estimation in an industrial antibiotic fermentation. Biotechnol. Bioeng. 2002, 78, 658-669.
-
(2002)
Biotechnol. Bioeng.
, vol.78
, pp. 658-669
-
-
Cunha, C.C.F.1
Glassey, J.2
Montague, G.A.3
Albert, S.4
Mohan, P.5
-
10
-
-
0036010282
-
Automated production support for the bioprocess industry.
-
Lennox, B., Kipling, K., Glassey, J., Montague, G. et al., Automated production support for the bioprocess industry. Biotechnol. Prog. 2002, 18, 269-275.
-
(2002)
Biotechnol. Prog.
, vol.18
, pp. 269-275
-
-
Lennox, B.1
Kipling, K.2
Glassey, J.3
Montague, G.4
-
11
-
-
10644262099
-
On-line multi-analyzer monitoring of biomass, glucose and acetate for growth rate control of a Vibrio cholerae fed-batch cultivation.
-
Navratil, M., Norberg, A., Lembren, L., Mandenius, C.-F., On-line multi-analyzer monitoring of biomass, glucose and acetate for growth rate control of a Vibrio cholerae fed-batch cultivation. J. Biotechnol. 2005, 115, 67-79.
-
(2005)
J. Biotechnol.
, vol.115
, pp. 67-79
-
-
Navratil, M.1
Norberg, A.2
Lembren, L.3
Mandenius, C.-F.4
-
12
-
-
70350247465
-
On-line estimation of biomass, glucose and ethanol in Saccharomyces cerevisiae cultivations using in-situ multi-wavelength fluorescence and software sensors.
-
Ödman, P., Johansen, S. L., Olsson, L., Gernaey, K. V., Lantz, A. E., On-line estimation of biomass, glucose and ethanol in Saccharomyces cerevisiae cultivations using in-situ multi-wavelength fluorescence and software sensors. J. Biotechnol. 2009, 144, 102-112.
-
(2009)
J. Biotechnol.
, vol.144
, pp. 102-112
-
-
Ödman, P.1
Johansen, S.L.2
Olsson, L.3
Gernaey, K.V.4
Lantz, A.E.5
-
13
-
-
0028483476
-
Monitoring batch processes using multi-way principal component analysis.
-
Nomikos, P., MacGregor, J. F., Monitoring batch processes using multi-way principal component analysis. AIChE J. 1994, 40, 1361-1375.
-
(1994)
AIChE J.
, vol.40
, pp. 1361-1375
-
-
Nomikos, P.1
MacGregor, J.F.2
-
14
-
-
0034609602
-
Physiological state specific models in estimation of recombinant Escherichia coli fermentation performance.
-
Feng, M., Glassey, J., Physiological state specific models in estimation of recombinant Escherichia coli fermentation performance. Biotechnol. Bioeng. 2000, 69, 494-593.
-
(2000)
Biotechnol. Bioeng.
, vol.69
, pp. 494-593
-
-
Feng, M.1
Glassey, J.2
-
15
-
-
33749333085
-
Retrospective optimization of time-dependent fermentation control strategies using time-independent historical data.
-
Coleman, M. C., Block, D. E., Retrospective optimization of time-dependent fermentation control strategies using time-independent historical data. Biotechnol. Bioeng. 2006, 95, 412-423.
-
(2006)
Biotechnol. Bioeng.
, vol.95
, pp. 412-423
-
-
Coleman, M.C.1
Block, D.E.2
-
16
-
-
11144263731
-
Classification of two-dimensional fluorescence spectra using self-organizing maps.
-
Rhee, J. I., Lee, K. I., Kim, C. K., Yim, Y. S. et al., Classification of two-dimensional fluorescence spectra using self-organizing maps. Biochem. Eng. J. 2005, 22, 135-144.
-
(2005)
Biochem. Eng. J.
, vol.22
, pp. 135-144
-
-
Rhee, J.I.1
Lee, K.I.2
Kim, C.K.3
Yim, Y.S.4
-
17
-
-
33644890191
-
Prediction of key state variables using support vector machines in bioprocesses.
-
Li, Y., Yuan, J., Prediction of key state variables using support vector machines in bioprocesses. Chem. Eng. Technol. 2006, 29, 313-319.
-
(2006)
Chem. Eng. Technol.
, vol.29
, pp. 313-319
-
-
Li, Y.1
Yuan, J.2
-
18
-
-
0024650558
-
Bioprocess simulation: an integrated approach to process development.
-
Petrides, D., Cooney, C. L., Evans, L. B., Field, R. P., Snoswell, M., Bioprocess simulation: an integrated approach to process development. Computers Chem. Eng. 1989, 13, 553-561.
-
(1989)
Computers Chem. Eng.
, vol.13
, pp. 553-561
-
-
Petrides, D.1
Cooney, C.L.2
Evans, L.B.3
Field, R.P.4
Snoswell, M.5
-
19
-
-
33846056506
-
Combining six-sigma with integrated design and control for yield enhancement in bioprocessing.
-
Dassau, E., Zadok, I., Lewin, D. R., Combining six-sigma with integrated design and control for yield enhancement in bioprocessing. Ind. Eng. Chem. Res. 2006, 45, 8299-8309.
-
(2006)
Ind. Eng. Chem. Res.
, vol.45
, pp. 8299-8309
-
-
Dassau, E.1
Zadok, I.2
Lewin, D.R.3
-
20
-
-
50049099382
-
Matrix notation for efficient development of first-principles models within PAT applications: Integrated modeling of antibiotic production with Streptomyces coelicolor.
-
Sin, G., Ödman, P., Petersen, N., Eliasson Lantz, A., Gernaey, K. V., Matrix notation for efficient development of first-principles models within PAT applications: Integrated modeling of antibiotic production with Streptomyces coelicolor. Biotechnol. Bioeng. 2008, 101, 153-171.
-
(2008)
Biotechnol. Bioeng.
, vol.101
, pp. 153-171
-
-
Sin, G.1
Ödman, P.2
Petersen, N.3
Eliasson Lantz, A.4
Gernaey, K.V.5
-
21
-
-
69649084328
-
Determining critical process parameters and process robustness in preparative chromatography - A model-based approach.
-
Degerman, M., Westerberg, K., Nilsson, B., Determining critical process parameters and process robustness in preparative chromatography - A model-based approach. Chem. Eng. Technol. 2009, 32, 903-911.
-
(2009)
Chem. Eng. Technol.
, vol.32
, pp. 903-911
-
-
Degerman, M.1
Westerberg, K.2
Nilsson, B.3
-
22
-
-
56949093864
-
Model-based computer aided framework for design of process monitoring and analysis systems.
-
Singh, R., Gernaey, K. V., Gani, R., Model-based computer aided framework for design of process monitoring and analysis systems. Computers Chem. Eng. 2009, 33, 22-42.
-
(2009)
Computers Chem. Eng.
, vol.33
, pp. 22-42
-
-
Singh, R.1
Gernaey, K.V.2
Gani, R.3
-
23
-
-
73249131640
-
Application of modeling and simulation tools for the evaluation of biocatalytic processes: A future perspective.
-
Sin, G., Woodley, J. M., Gernaey, K. V., Application of modeling and simulation tools for the evaluation of biocatalytic processes: A future perspective. Biotechnol. Prog. 2009, 25, 1529-1538.
-
(2009)
Biotechnol. Prog.
, vol.25
, pp. 1529-1538
-
-
Sin, G.1
Woodley, J.M.2
Gernaey, K.V.3
-
24
-
-
77953913430
-
Application of mechanistic models to fermentation and biocatalysis for next generation processes.
-
Gernaey, K. V., Eliasson Lantz, A., Tufvesson, P., Woodley, J. M., Sin, G., Application of mechanistic models to fermentation and biocatalysis for next generation processes. Trends Biotechnol. 2010, 28, 346-354.
-
(2010)
Trends Biotechnol.
, vol.28
, pp. 346-354
-
-
Gernaey, K.V.1
Eliasson Lantz, A.2
Tufvesson, P.3
Woodley, J.M.4
Sin, G.5
-
25
-
-
0019274412
-
Application of macroscopic principles to microbial metabolism.
-
Roels, J. A., Application of macroscopic principles to microbial metabolism. Biotechnol. Bioeng. 1980, 22, 2457-2514.
-
(1980)
Biotechnol. Bioeng.
, vol.22
, pp. 2457-2514
-
-
Roels, J.A.1
-
26
-
-
77957357262
-
A model-based systems approach to pharmaceutical product-process design and analysis.
-
Gernaey, K. V., Gani, R., A model-based systems approach to pharmaceutical product-process design and analysis. Chem. Eng. Sci. 2010, 65, 5757-5769.
-
(2010)
Chem. Eng. Sci.
, vol.65
, pp. 5757-5769
-
-
Gernaey, K.V.1
Gani, R.2
-
27
-
-
0026223316
-
Linear relations in microbial reaction systems: A general overview of their origin, form and use.
-
Noorman, H. J., Heijnen, J. J., Luyben, C. K. A. M., Linear relations in microbial reaction systems: A general overview of their origin, form and use. Biotechnol. Bioeng. 1991, 38, 603-618.
-
(1991)
Biotechnol. Bioeng.
, vol.38
, pp. 603-618
-
-
Noorman, H.J.1
Heijnen, J.J.2
Luyben, C.K.A.M.3
-
28
-
-
68049104423
-
Good modelling practice (GMoP) for PAT applications: Propagation of input uncertainty and sensitivity analysis.
-
Sin, G., Gernaey, K. V., Eliasson Lantz, A., Good modelling practice (GMoP) for PAT applications: Propagation of input uncertainty and sensitivity analysis. Biotechnol. Prog. 2009, 25, 1043-1053.
-
(2009)
Biotechnol. Prog.
, vol.25
, pp. 1043-1053
-
-
Sin, G.1
Gernaey, K.V.2
Eliasson Lantz, A.3
-
29
-
-
68849103534
-
Global sensitivity analysis challenges in biological systems modeling.
-
Kiparissides, A., Kucherenko, S. S., Mantalaris, A., Pistikopoulos, E. N., Global sensitivity analysis challenges in biological systems modeling. Ind. Eng. Chem. Res. 2009, 48, 7168-7180.
-
(2009)
Ind. Eng. Chem. Res.
, vol.48
, pp. 7168-7180
-
-
Kiparissides, A.1
Kucherenko, S.S.2
Mantalaris, A.3
Pistikopoulos, E.N.4
-
30
-
-
69349091231
-
Modelling and simulation of a transketolase mediated reaction: Sensitivity analysis of kinetic parameters.
-
Sayar, N. A., Chen, B.H., Lye, G.J., Woodley, J. M., Modelling and simulation of a transketolase mediated reaction: Sensitivity analysis of kinetic parameters. Biochem. Eng. J. 2009, 47, 1-9.
-
(2009)
Biochem. Eng. J.
, vol.47
, pp. 1-9
-
-
Sayar, N.A.1
Chen, B.H.2
Lye, G.J.3
Woodley, J.M.4
-
31
-
-
0141908157
-
Tuning the transcription rate of recombinant protein in strong Escherichia coli expression systems through repressor titration.
-
Striedner, G., Cserjan-Puschmann, M., Pötschacher, F., Bayer, K., Tuning the transcription rate of recombinant protein in strong Escherichia coli expression systems through repressor titration. Biotechnol. Prog. 2003, 19, 1427-1432.
-
(2003)
Biotechnol. Prog.
, vol.19
, pp. 1427-1432
-
-
Striedner, G.1
Cserjan-Puschmann, M.2
Pötschacher, F.3
Bayer, K.4
-
32
-
-
33745482610
-
Improvement of bioprocess monitoring: development of novel concepts.
-
Clementschitsch, F., Bayer, K., Improvement of bioprocess monitoring: development of novel concepts. Microb. Cell Fact. 2006, 5, 19.
-
(2006)
Microb. Cell Fact.
, vol.5
, pp. 19
-
-
Clementschitsch, F.1
Bayer, K.2
-
33
-
-
26444526644
-
Sensor combination and chemometric modelling for improved process monitoring in recombinant E. coli fed-batch cultivations.
-
Clementschitsch, F., Jürgen, K., Florentina, P., Bayer, K., Sensor combination and chemometric modelling for improved process monitoring in recombinant E. coli fed-batch cultivations. J. Biotechnol. 2005, 120, 183-196.
-
(2005)
J. Biotechnol.
, vol.120
, pp. 183-196
-
-
Clementschitsch, F.1
Jürgen, K.2
Florentina, P.3
Bayer, K.4
-
34
-
-
77449109660
-
Plasmid-free T7-based Escherichia coli expression systems.
-
Striedner, G., Pfaffenzeller, I., Markus, L., Nemecek, S. et al., Plasmid-free T7-based Escherichia coli expression systems. Biotechnol. Bioeng. 2010, 105, 786-794.
-
(2010)
Biotechnol. Bioeng.
, vol.105
, pp. 786-794
-
-
Striedner, G.1
Pfaffenzeller, I.2
Markus, L.3
Nemecek, S.4
-
35
-
-
8344271026
-
Production of recombinant protein therapeutics in cultivated mammalian cells.
-
Wurm, F., Production of recombinant protein therapeutics in cultivated mammalian cells. Nat. Biotechnol. 2004, 22, 1393-1398.
-
(2004)
Nat. Biotechnol.
, vol.22
, pp. 1393-1398
-
-
Wurm, F.1
-
36
-
-
33847613926
-
Process economics of industrial monoclonal antibody manufacture.
-
Farid, S. S., Process economics of industrial monoclonal antibody manufacture. J. Chromatogr. B 2007, 848, 8-18.
-
(2007)
J. Chromatogr. B
, vol.848
, pp. 8-18
-
-
Farid, S.S.1
-
37
-
-
34548580170
-
Advances in antibody manufacturing using mammalian cells.
-
Morrow, K. J., Advances in antibody manufacturing using mammalian cells. Biotechnol. Annu. Rev. 2007, 13, 95-113.
-
(2007)
Biotechnol. Annu. Rev.
, vol.13
, pp. 95-113
-
-
Morrow, K.J.1
-
38
-
-
4544365911
-
Economic aspects of commercial manufacture of biopharmaceuticals.
-
Werner, R. G., Economic aspects of commercial manufacture of biopharmaceuticals. J. Biotechnol. 2004, 113, 171-182.
-
(2004)
J. Biotechnol.
, vol.113
, pp. 171-182
-
-
Werner, R.G.1
-
39
-
-
12544253860
-
Impact of dynamic online fed-batch strategies on metabolism, productivity and N-glycosylation quality in CHO cell cultures.
-
Wong, D. C. F., Wong, K. T. K., Goh, L. T., Heng, C. K., Yap, M. G. S., Impact of dynamic online fed-batch strategies on metabolism, productivity and N-glycosylation quality in CHO cell cultures. Biotechnol. Bioeng. 2005, 89, 164-177.
-
(2005)
Biotechnol. Bioeng.
, vol.89
, pp. 164-177
-
-
Wong, D.C.F.1
Wong, K.T.K.2
Goh, L.T.3
Heng, C.K.4
Yap, M.G.S.5
-
40
-
-
68149141804
-
Identification of cell culture conditions to control N-glycosylation site-occupancy of recombinant glycoproteins expressed in CHO cells.
-
Gawlitzek, M., Estacio, M., Fürch, T., Kiss, R., Identification of cell culture conditions to control N-glycosylation site-occupancy of recombinant glycoproteins expressed in CHO cells. Biotechnol. Bioeng. 2009, 103, 1164-1175.
-
(2009)
Biotechnol. Bioeng.
, vol.103
, pp. 1164-1175
-
-
Gawlitzek, M.1
Estacio, M.2
Fürch, T.3
Kiss, R.4
-
41
-
-
21344466364
-
Metabolic footprinting and systems biology: The medium is the message.
-
Kell, D. B., Brown, M., Davey, H. M., Dunn, W. B. et al., Metabolic footprinting and systems biology: The medium is the message. Nat. Rev. Microbiol. 2005, 3, 557-565.
-
(2005)
Nat. Rev. Microbiol.
, vol.3
, pp. 557-565
-
-
Kell, D.B.1
Brown, M.2
Davey, H.M.3
Dunn, W.B.4
-
42
-
-
33847358695
-
Analytical strategies in metabonomics.
-
Lenz, E. V., Wilson, I. D., Analytical strategies in metabonomics. J. Proteome Res. 2007, 6, 443-458.
-
(2007)
J. Proteome Res.
, vol.6
, pp. 443-458
-
-
Lenz, E.V.1
Wilson, I.D.2
-
43
-
-
33846017352
-
The nature of systems biology.
-
Bruggeman, F. J., Westerhoff, H. V., The nature of systems biology. Trends Microbiol. 2007, 15, 45-50.
-
(2007)
Trends Microbiol.
, vol.15
, pp. 45-50
-
-
Bruggeman, F.J.1
Westerhoff, H.V.2
-
44
-
-
33847174152
-
Oliveira, R. Hybrid elementary flux analysis/nonparametric modeling: application for bioprocess control
-
Teixeira, A. P., Alves, C., Alves, P. M., Carrondo, M. J. T., Oliveira, R. Hybrid elementary flux analysis/nonparametric modeling: application for bioprocess control, BMC Bioinformatics 2007, 8, 30.
-
(2007)
BMC Bioinformatics
, vol.8
, pp. 30
-
-
Teixeira, A.P.1
Alves, C.2
Alves, P.M.3
Carrondo, M.J.T.4
-
45
-
-
35748956436
-
Hybrid semi-parametric mathematical systems: Bridging the gap between systems biology and process engineering.
-
Teixeira, A. P., Carinhas, N., Dias, J. M. L., Cruz, P. et al., Hybrid semi-parametric mathematical systems: Bridging the gap between systems biology and process engineering. J. Biotechnol. 2007, 132, 418-425.
-
(2007)
J. Biotechnol.
, vol.132
, pp. 418-425
-
-
Teixeira, A.P.1
Carinhas, N.2
Dias, J.M.L.3
Cruz, P.4
|