-
1
-
-
84872410762
-
Analysis of the landscape of biologically-derived pharmaceuticals in Europe: Dominant production systems, molecule types on the rise and approval trends
-
Kyriakopoulos S, Kontoravdi C: Analysis of the landscape of biologically-derived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends. Eur J Pharmaceut Sci 2012, 48:428-441.
-
(2012)
Eur J Pharmaceut Sci
, vol.48
, pp. 428-441
-
-
Kyriakopoulos, S.1
Kontoravdi, C.2
-
2
-
-
84899978047
-
-
Pharmaceutical Development Q8(R2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
-
Pharmaceutical Development Q8(R2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/ Quality/Q8-R1/ Step4/Q8-R2-Guideline.pdf.
-
-
-
-
3
-
-
60149106150
-
Quality by design for biopharmaceuticals
-
Rathore AS, Winkle H: Quality by design for biopharmaceuticals. Nat Biotechnol 2009, 27:26-34.
-
(2009)
Nat Biotechnol
, vol.27
, pp. 26-34
-
-
Rathore, A.S.1
Winkle, H.2
-
4
-
-
84873701785
-
Application of quality by design to the development of analytical separation methods
-
Orlandini S, Pinzauti S, Furlanetto S: Application of quality by design to the development of analytical separation methods. Anal Bioanal Chem 2013, 405:443-450.
-
(2013)
Anal Bioanal Chem
, vol.405
, pp. 443-450
-
-
Orlandini, S.1
Pinzauti, S.2
Furlanetto, S.3
-
5
-
-
84865987423
-
Ishikawa cause and effect diagrams using capture recapture techniques
-
Bilsel RU, Lin DKJ: Ishikawa cause and effect diagrams using capture recapture techniques. Qual Technol Quantit Manage 2012, 9:137-152.
-
(2012)
Qual Technol Quantit Manage
, vol.9
, pp. 137-152
-
-
Bilsel, R.U.1
Lin, D.K.J.2
-
6
-
-
43349088601
-
Pharmaceutical quality by design: Product and process development, understanding, and control
-
Yu LX: Pharmaceutical quality by design: product and process development, understanding, and control. Pharm Res 2008, 25:781-791.
-
(2008)
Pharm Res
, vol.25
, pp. 781-791
-
-
Yu, L.X.1
-
7
-
-
84874020997
-
Process systems engineering tools in the pharmaceutical industry
-
Troup GM, Georgakis C: Process systems engineering tools in the pharmaceutical industry. Comput Chem Eng 2013, 51:157-171.
-
(2013)
Comput Chem Eng
, vol.51
, pp. 157-171
-
-
Troup, G.M.1
Georgakis, C.2
-
8
-
-
84869876139
-
The dynamics of the CHO host cell protein profile during clarification and protein A capture in a platform antibody purification process
-
Hogwood CEM, Tait AS, Koloteva-Levine N, Bracewell DG, Smales CM: The dynamics of the CHO host cell protein profile during clarification and protein A capture in a platform antibody purification process. Biotechnol Bioeng 2013, 110:240-251.
-
(2013)
Biotechnol Bioeng
, vol.110
, pp. 240-251
-
-
Hogwood, C.E.M.1
Tait, A.S.2
Koloteva-Levine, N.3
Bracewell, D.G.4
Smales, C.M.5
-
11
-
-
84865369903
-
Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi-step design space
-
Eon-Duval A, Valax P, Solacroup T, Broly H, Gleixner R, Le Strat C, Sutter J: Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space. J Pharm Sci 2012, 101:3604-3618.
-
(2012)
J Pharm Sci
, vol.101
, pp. 3604-3618
-
-
Eon-Duval, A.1
Valax, P.2
Solacroup, T.3
Broly, H.4
Gleixner, R.5
Le Strat, C.6
Sutter, J.7
-
12
-
-
0027112086
-
Use of a structured kinetic-model of antibody-synthesis and secretion for optimization of antibody-production systems
-
Bibila TA, Flickinger MC: Use of a structured kinetic-model of antibody-synthesis and secretion for optimization of antibody-production systems. 2. Transient analysis. Biotechnol Bioeng 1992, 39:262-272.
-
(1992)
2. Transient Analysis. Biotechnol Bioeng
, vol.39
, pp. 262-272
-
-
Bibila, T.A.1
Flickinger, M.C.2
-
13
-
-
0029104088
-
In pursuit of the optimal fed-batch process for monoclonal-antibody production
-
Bibila TA, Robinson DK: In pursuit of the optimal fed-batch process for monoclonal-antibody production. Biotechnol Progress 1995, 11:1-13.
-
(1995)
Biotechnol Progress
, vol.11
, pp. 1-13
-
-
Bibila, T.A.1
Robinson, D.K.2
-
14
-
-
0034688179
-
Dynamic optimization of hybridoma growth in a fed-batch bioreactor
-
DOI 10.1002/ (SICI) 1097-0290 (20000120) 67:2<197::AID-BIT9>3.0. CO;2-W
-
Dhir S, Morrow KJ, Rhinehart RR, Wiesner T: Dynamic optimization of hybridoma growth in a fed-batch bioreactor. Biotechnol Bioeng 2000, 67:197-205. (Pubitemid 30029781)
-
(2000)
Biotechnology and Bioengineering
, vol.67
, Issue.2
, pp. 197-205
-
-
Dhir, S.1
Morrow Jr., K.J.2
Rhinehart, R.R.3
Wiesner, T.4
-
15
-
-
0942265268
-
Maximizing Interferon-γ Production by Chinese Hamster Ovary Cells Through Temperature Shift Optimization: Experimental and Modeling
-
DOI 10.1002/bit.10861
-
Fox SR, Patel UA, Yap MGS, Wang DIC: Maximizing interferon- gamma production by Chinese hamster ovary cells through temperature shift optimization: experimental and modeling. Biotechnol Bioeng 2004, 85:177-184. (Pubitemid 38141119)
-
(2004)
Biotechnology and Bioengineering
, vol.85
, Issue.2
, pp. 177-184
-
-
Fox, S.R.1
Patel, U.A.2
Yap, M.G.S.3
Wang, D.I.C.4
-
16
-
-
84873294303
-
Process model comparison and transferability across bioreactor scales and modes of operation for a mammalian cell bioprocess
-
Craven S, Shirsat N, Whelan J, Glennon B: Process model comparison and transferability across bioreactor scales and modes of operation for a mammalian cell bioprocess. Biotechnol Progress 2013, 29:186-196.
-
(2013)
Biotechnol Progress
, vol.29
, pp. 186-196
-
-
Craven, S.1
Shirsat, N.2
Whelan, J.3
Glennon, B.4
-
17
-
-
78650525718
-
Dynamic model of CHO cell metabolism
-
Nolan RP, Lee K: Dynamic model of CHO cell metabolism. Metab Eng 2011, 13:108-124.
-
(2011)
Metab Eng
, vol.13
, pp. 108-124
-
-
Nolan, R.P.1
Lee, K.2
-
18
-
-
84862784156
-
Combined in silico modeling and metabolomics analysis to characterize fed-batch CHO cell culture
-
Selvarasu S, Ho YS, Chong WPK, Wong NSC, Yusufi FNK, Lee YY, Yap MGS, Lee DY: Combined in silico modeling and metabolomics analysis to characterize fed-batch CHO cell culture. Biotechnol Bioeng 2012, 109:1415-1429.
-
(2012)
Biotechnol Bioeng
, vol.109
, pp. 1415-1429
-
-
Selvarasu, S.1
Ho, Y.S.2
Chong, W.P.K.3
Wong, N.S.C.4
Yusufi, F.N.K.5
Lee, Y.Y.6
Yap, M.G.S.7
Lee, D.Y.8
-
19
-
-
2342632479
-
Cell population balance modeling and control in continuous bioreactors
-
Mantzaris NV, Daoutidis P: Cell population balance modeling and control in continuous bioreactors. J Process Control 2004, 14:775-784.
-
(2004)
J Process Control
, vol.14
, pp. 775-784
-
-
Mantzaris, N.V.1
Daoutidis, P.2
-
20
-
-
80053439474
-
Experimental methods and modeling techniques for description of cell population heterogeneity
-
Fernandes RL, Nierychlo M, Lundin L, Pedersen AE, Tellez PEP, Dutta A, Carlquist M, Bolic A, Schapper D, Brunetti AC et al.: Experimental methods and modeling techniques for description of cell population heterogeneity. Biotechnol Adv 2011, 29:575-599.
-
(2011)
Biotechnol Adv
, vol.29
, pp. 575-599
-
-
Fernandes, R.L.1
Nierychlo, M.2
Lundin, L.3
Pedersen, A.E.4
Tellez, P.E.P.5
Dutta, A.6
Carlquist, M.7
Bolic, A.8
Schapper, D.9
Brunetti, A.C.10
-
21
-
-
82955237386
-
A dynamic mathematical model for monoclonal antibody N-linked glycosylation and nucleotide sugar donor transport within a maturing Golgi apparatus
-
Jimenez del Val I, Nagy JM, Kontoravdi C: A dynamic mathematical model for monoclonal antibody N-linked glycosylation and nucleotide sugar donor transport within a maturing Golgi apparatus. Biotechnol Prog 2011, 27:1730-1743.
-
(2011)
Biotechnol Prog
, vol.27
, pp. 1730-1743
-
-
Jimenez Del Val, I.1
Nagy, J.M.2
Kontoravdi, C.3
-
22
-
-
84874992105
-
Chromatography modelling to describe protein adsorption at bead level
-
Gerontas S, Shapiro MS, Bracewell DG: Chromatography modelling to describe protein adsorption at bead level. J Chromatogr A 2013, 1284:44-52.
-
(2013)
J Chromatogr A
, vol.1284
, pp. 44-52
-
-
Gerontas, S.1
Shapiro, M.S.2
Bracewell, D.G.3
-
23
-
-
37349120092
-
Quality by design-Thermodynamic modelling of chromatographic separation of proteins
-
DOI 10.1016/j.chroma.2007.08.059, PII S002196730701429X
-
Mollerup JM, Hansen TB, Kidal S, Staby A: Quality by design - thermodynamic modelling of chromatographic separation of proteins. J Chromatogr A 2008, 1177:200-206. (Pubitemid 350299029)
-
(2008)
Journal of Chromatography A
, vol.1177
, Issue.2
, pp. 200-206
-
-
Mollerup, J.M.1
Hansen, T.B.2
Kidal, S.3
Staby, A.4
-
24
-
-
84874956328
-
Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture
-
Pollock J, Bolton G, Coffman J, Ho SV, Bracewell DG, Farid SS: Optimising the design and operation of semi-continuous affinity chromatography for clinical and commercial manufacture. J Chromatogr A 2013, 1284:17-27.
-
(2013)
J Chromatogr A
, vol.1284
, pp. 17-27
-
-
Pollock, J.1
Bolton, G.2
Coffman, J.3
Ho, S.V.4
Bracewell, D.G.5
Farid, S.S.6
-
25
-
-
84875965514
-
Integration of stochastic simulation with multivariate analysis: Short-term facility fit prediction
-
Stonier A, Pain D, Westlake A, Hutchinson N, Thornhill NF, Farid SS: Integration of stochastic simulation with multivariate analysis: short-term facility fit prediction. Biotechnol Progress 2013, 29:368-377.
-
(2013)
Biotechnol Progress
, vol.29
, pp. 368-377
-
-
Stonier, A.1
Pain, D.2
Westlake, A.3
Hutchinson, N.4
Thornhill, N.F.5
Farid, S.S.6
-
26
-
-
79960146499
-
Model simulation and experimental verification of a cation-exchange IgG capture step in batch and continuous chromatography
-
Muller-Spath T, Strohlein G, Aumann L, Kornmann H, Valax P, Delegrange L, Charbaut E, Baer G, Lamproye A, Johnck M et al.: Model simulation and experimental verification of a cation-exchange IgG capture step in batch and continuous chromatography. J Chromatogr A 2011, 1218:5195-5204.
-
(2011)
J Chromatogr A
, vol.1218
, pp. 5195-5204
-
-
Muller-Spath, T.1
Strohlein, G.2
Aumann, L.3
Kornmann, H.4
Valax, P.5
Delegrange, L.6
Charbaut, E.7
Baer, G.8
Lamproye, A.9
Johnck, M.10
-
27
-
-
84864564777
-
Simulation model for overloaded monoclonal antibody variants separations in ionexchange chromatography
-
Guelat B, Strohlein G, Lattuada M, Delegrange L, Valax P, Morbidelli M: Simulation model for overloaded monoclonal antibody variants separations in ionexchange chromatography. J Chromatogr A 2012, 1253:32-43.
-
(2012)
J Chromatogr A
, vol.1253
, pp. 32-43
-
-
Guelat, B.1
Strohlein, G.2
Lattuada, M.3
Delegrange, L.4
Valax, P.5
Morbidelli, M.6
-
28
-
-
84865559197
-
An MILP formulation for the synthesis of protein purification processes
-
Polykarpou EM, Dalby PA, Papageorgiou LG: An MILP formulation for the synthesis of protein purification processes. Chem Eng Res Des 2012, 90:1262-1270.
-
(2012)
Chem Eng Res des
, vol.90
, pp. 1262-1270
-
-
Polykarpou, E.M.1
Dalby, P.A.2
Papageorgiou, L.G.3
-
29
-
-
84874989385
-
Model-based design space determination of peptide chromatographic purification processes
-
Getaz D, Butte A, Morbidelli M: Model-based design space determination of peptide chromatographic purification processes. J Chromatogr A 2013, 1284:80-87.
-
(2013)
J Chromatogr A
, vol.1284
, pp. 80-87
-
-
Getaz, D.1
Butte, A.2
Morbidelli, M.3
-
30
-
-
85030412762
-
-
Global Vaccine Market Forecast to
-
Global Vaccine Market Forecast to 2017. http:// www.researchandmarkets. com/research/jdxsk3/global-vaccine.
-
-
-
-
32
-
-
0030189663
-
MILP model for scheduling and design of a special class of multipurpose batch plants
-
Voudouris VT, Grossmann IE: MILP model for scheduling and design of a special class of multipurpose batch plants. Comput Chem Eng 1996, 20:1335-1360.
-
(1996)
Comput Chem Eng
, vol.20
, pp. 1335-1360
-
-
Voudouris, V.T.1
Grossmann, I.E.2
-
34
-
-
33745570852
-
Modelling and planning optimization of a complex flu vaccine facility
-
DOI 10.1205/fbp.05001
-
Tsang KH, Samsatli NJ, Shah N: Modelling and planning optimization of a complex flu vaccine facility. Food Bioprod Process 2006, 84:123-134. (Pubitemid 43978146)
-
(2006)
Food and Bioproducts Processing
, vol.84
, Issue.2
, pp. 123-134
-
-
Tsang, K.H.1
Samsatli, N.J.2
Shah, N.3
-
35
-
-
33748483846
-
Humanization of yeast to produce complex terminally sialylated glycoproteins
-
DOI 10.1126/science.1130256
-
Hamilton SR, Davidson RC, Sethuraman N, Nett JH, Jiang Y, Rios S, Bobrowicz P, Stadheim TA, Li H, Choi B-K et al.: Humanization of yeast to produce complex terminally sialylated glycoproteins. Science 2006, 313:1441-1443. (Pubitemid 44360273)
-
(2006)
Science
, vol.313
, Issue.5792
, pp. 1441-1443
-
-
Hamilton, S.R.1
Davidson, R.C.2
Sethuraman, N.3
Nett, J.H.4
Jiang, Y.5
Rios, S.6
Bobrowicz, P.7
Stadheim, T.A.8
Li, H.9
Choi, B.-K.10
Hopkins, D.11
Wischnewski, H.12
Roser, J.13
Mitchell, T.14
Strawbridge, R.R.15
Hoopes, J.16
Wildt, S.17
Gerngross, T.U.18
-
36
-
-
0034026065
-
Foreign protein production in plant tissue cultures
-
DOI 10.1016/S0958-1669(00)00086-0
-
Doran PM: Foreign protein production in plant tissue cultures. Curr Opin Biotechnol 2000, 11:199-204. (Pubitemid 30182316)
-
(2000)
Current Opinion in Biotechnology
, vol.11
, Issue.2
, pp. 199-204
-
-
Doran, P.M.1
-
37
-
-
84863617589
-
Synthetic biology - The state of play
-
Kitney R, Freemont P: Synthetic biology - the state of play. FEBS Lett 2012, 586:2029-2036.
-
(2012)
FEBS Lett
, vol.586
, pp. 2029-2036
-
-
Kitney, R.1
Freemont, P.2
-
38
-
-
85030413547
-
-
Shaping the Biosimilars Opportunity: A Global Perspective on the Evolving Biosimilars Landscape
-
Shaping the Biosimilars Opportunity: A Global Perspective on the Evolving Biosimilars Landscape. http://www.imshealth.com/ims/ Global/Content/ Home%20Page%20Content/IMS%20News/ Biosimilars-Whitepaper.pdf.
-
-
-
-
39
-
-
84863075257
-
Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online twodimensional liquid chromatography/mass spectrometry
-
Doneanu CE, Xenopoulos A, Fadgen K, Murphy J, Skilton SJ, Prentice H, Stapels M, Chen WB: Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online twodimensional liquid chromatography/mass spectrometry. mAbs 2012, 4:24-44.
-
(2012)
MAbs
, vol.4
, pp. 24-44
-
-
Doneanu, C.E.1
Xenopoulos, A.2
Fadgen, K.3
Murphy, J.4
Skilton, S.J.5
Prentice, H.6
Stapels, M.7
Chen, W.B.8
-
40
-
-
79961236820
-
Multiplexed analytical glycomics: Rapid and confident IgG N-glycan structural elucidation
-
Mittermayr S, Bones J, Doherty M, Guttman A, Rudd PM: Multiplexed analytical glycomics: rapid and confident IgG N-glycan structural elucidation. J Proteome Res 2011, 10:3820-3829.
-
(2011)
J Proteome Res
, vol.10
, pp. 3820-3829
-
-
Mittermayr, S.1
Bones, J.2
Doherty, M.3
Guttman, A.4
Rudd, P.M.5
|