-
1
-
-
79951920084
-
-
Retrieved July 3, 2012 from
-
ICH. Pharmaceutical development. Q8(R2). Current Step 4'. Retrieved July 3, 2012 from http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/ Guidelines/Quality/Q8-R1/Step4/Q8-R2-Guideline.pdf, 2009.
-
(2009)
Pharmaceutical Development. Q8(fpag R2). Current Step 4
-
-
-
2
-
-
20744445884
-
-
Retrieved July 3, 2012 from
-
U.S. Food and Drug Administration (FDA). Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach. Retrieved July 3, 2012 fromhttp://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/ QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374. pdf, 2004.
-
(2004)
Pharmaceutical CGMPs for the 21st Century - A Risk-Based Approach
-
-
-
5
-
-
44649110792
-
PQLI key topics - Criticality, design space, and control strategy
-
Garcia, T.; Cook, G.; Nosal, R. PQLI key topics - criticality, design space, and control strategy. J. Pharm. Innov. 2008, 3 (2), 60 - 68.
-
(2008)
J. Pharm. Innov.
, vol.3
, Issue.2
, pp. 60-68
-
-
Garcia, T.1
Cook, G.2
Nosal, R.3
-
6
-
-
8344224534
-
Characterizing biological products and assessing comparability following manufacturing changes
-
Chirino, A. J.; Mire-Sluis, A. Characterizing biological products and assessing comparability following manufacturing changes. Nature Biotechnol. 2004, 22 (11), 1383-1391.
-
(2004)
Nature Biotechnol.
, vol.22
, Issue.11
, pp. 1383-1391
-
-
Chirino, A.J.1
Mire-Sluis, A.2
-
7
-
-
45149110911
-
Defining process design space for biotech products: Case study of Pichia pastoris fermentation
-
Harms, J.; Wang, X.; Kim, T.; Yang, X.; Rathore, A. S. Defining process design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol. Prog. 2008, 24 (3), 655- 662.
-
(2008)
Biotechnol. Prog.
, vol.24
, Issue.3
, pp. 655-662
-
-
Harms, J.1
Wang, X.2
Kim, T.3
Yang, X.4
Rathore, A.S.5
-
8
-
-
44449122383
-
Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on-line high-performance liquid chromatography (HPLC) for making real-time pooling decisions for process chromatography
-
Rathore, A. S.; Yu, M.; Yeboah, S.; Sharma, A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high-performance liquid chromatography (HPLC) for making real-time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 100 (2), 306 -316.
-
(2008)
Biotechnol. Bioeng.
, vol.100
, Issue.2
, pp. 306-316
-
-
Rathore, A.S.1
Yu, M.2
Yeboah, S.3
Sharma, A.4
-
9
-
-
45249124065
-
Creating quality by design/process analytical technology (PAT/QbD) management awareness
-
Woelbeling, C. Creating quality by design/process analytical technology (PAT/QbD) management awareness. Pharm. Eng. 2008, 28, 1-9.
-
(2008)
Pharm. Eng.
, vol.28
, pp. 1-9
-
-
Woelbeling, C.1
-
10
-
-
43349088601
-
Pharmaceutical quality by design: Product and process development, understanding, and control
-
Yu, L. Pharmaceutical quality by design: product and process development, understanding, and control. Pharm. Res. 2008, 25 (4), 781-791.
-
(2008)
Pharm. Res.
, vol.25
, Issue.4
, pp. 781-791
-
-
Yu, L.1
-
11
-
-
70350208809
-
Quality by design case study: An integrated multivariate approach to drug product and process development
-
Huang, J.; Kaul, G.; Cai, C.; Chatlapalli, R.; Hernandez-Abad, P.; Ghosh, K.; Nagi, A. Quality by design case study: An integrated multivariate approach to drug product and process development. Int. J. Pharm. 2009, 382 (1-2), 23-32.
-
(2009)
Int. J. Pharm.
, vol.382
, Issue.1-2
, pp. 23-32
-
-
Huang, J.1
Kaul, G.2
Cai, C.3
Chatlapalli, R.4
Hernandez-Abad, P.5
Ghosh, K.6
Nagi, A.7
-
12
-
-
68049113335
-
Quality-by-design for biotechnology-related pharmaceuticals
-
Mandenius, C.-F.; Graumann, K.; Schultz, T. W.; Premstaller, A.; Olsson, I. M.; Petiot, E.; Clemens, C.; Welin, M. Quality-by-design for biotechnology-related pharmaceuticals. Biotechnology Journal 2009, 4 (5), 600 - 609.
-
(2009)
Biotechnology Journal
, vol.4
, Issue.5
, pp. 600-609
-
-
Mandenius, C.-F.1
Graumann, K.2
Schultz, T.W.3
Premstaller, A.4
Olsson, I.M.5
Petiot, E.6
Clemens, C.7
Welin, M.8
-
13
-
-
68749083515
-
Roadmap for implementation of quality by design (QbD) for biotechnology products
-
Rathore, A. S. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009, 27 (9), 546 -553.
-
(2009)
Trends Biotechnol
, vol.27
, Issue.9
, pp. 546-553
-
-
Rathore, A.S.1
-
15
-
-
77950805692
-
PAT Und QbD im regulatorischen Umfeld der Pharmazeutischen Industrie
-
Schmidt-Bader, T. PAT und QbD im regulatorischen Umfeld der Pharmazeutischen Industrie. Chemie Ingenieur Technik 2010, 82, 415- 428.
-
(2010)
Chemie Ingenieur Technik
, vol.82
, pp. 415-428
-
-
Schmidt-Bader, T.1
-
16
-
-
34247474373
-
Quality: Design space for biotech products
-
Anurag, P.; Rathore, S.; Branning, R.; Cecchini, D. Quality: design space for biotech products. BioPharm Int. 2007, 20 (4).
-
(2007)
BioPharm Int.
, vol.20
, Issue.4
-
-
Anurag, P.1
Rathore, S.2
Branning, R.3
Cecchini, D.4
-
17
-
-
84873622374
-
-
Washington, DC. Retrieved July 3, 2012 from
-
Winkle, H. Implementing Quality by Design, PDA/FDA Joint Regulatory Conference, Washington, DC. Retrieved July 3, 2012 from http://www.fda.gov/ downloads/AboutFDA/CentersOffices/CDER/ucm103453.pdf, 2012.
-
(2012)
Implementing Quality by Design, PDA/FDA Joint Regulatory Conference
-
-
Winkle, H.1
-
18
-
-
77956443855
-
Applied advanced process analytics in biopharmaceutical manufacturing: Challenges and prospects in real-time monitoring and control
-
Ündey, C.; Ertunç, S.; Mistretta, T.; Looze, B. Applied advanced process analytics in biopharmaceutical manufacturing: Challenges and prospects in real-time monitoring and control. J. Process Control 2010, 20 (9), 1009 -1018.
-
(2010)
J. Process Control
, vol.20
, Issue.9
, pp. 1009-1018
-
-
Ündey, C.1
Ertunç, S.2
Mistretta, T.3
Looze, B.4
-
19
-
-
0036500993
-
Systems biology: A brief overview
-
Kitano, H. Systems biology: a brief overview. Science 2002, 295, 1662-1664.
-
(2002)
Science
, vol.295
, pp. 1662-1664
-
-
Kitano, H.1
-
20
-
-
0141908157
-
Tuning the transcription rate of recombinant protein in strong Escherichia coli expression systems through repressor titration
-
Striedner, G.; Cserjan-Puschmann, M.; Potschacher, F.; Bayer, K. Tuning the transcription rate of recombinant protein in strong Escherichia coli expression systems through repressor titration. Biotechnol. Prog. 2003, 19 (5), 1427-1432.
-
(2003)
Biotechnol. Prog.
, vol.19
, Issue.5
, pp. 1427-1432
-
-
Striedner, G.1
Cserjan-Puschmann, M.2
Potschacher, F.3
Bayer, K.4
-
21
-
-
84856583859
-
Model-based analysis on the relationship of signal quality to realtime extraction of information in bioprocesses
-
Wechselberger P.; Herwig, C. Model-based analysis on the relationship of signal quality to realtime extraction of information in bioprocesses. Biotechnol. Prog. 2012, 28 (1), 265-275.
-
(2012)
Biotechnol. Prog.
, vol.28
, Issue.1
, pp. 265-275
-
-
Wechselberger, P.1
Herwig, C.2
-
22
-
-
0035813388
-
On-line stoichiometry and identification of metabolic state under dynamic process conditions
-
Herwig, C.; Marison, I.; von Stockar, U. On-line stoichiometry and identification of metabolic state under dynamic process conditions. Biotechnol. Bioeng. 2001, 75 (3), 345-354.
-
(2001)
Biotechnol. Bioeng.
, vol.75
, Issue.3
, pp. 345-354
-
-
Herwig, C.1
Marison, I.2
Von Stockar, U.3
-
23
-
-
83555177325
-
Effect of post-induction substrate oscillation on recombinant alkaline phosphatase production expressed in Escherichia coli
-
Jazini, M.; Herwig, C. Effect of post-induction substrate oscillation on recombinant alkaline phosphatase production expressed in Escherichia coli. J. Biosci. Bioeng. 2011, 112 (6), 606 - 610.
-
(2011)
J. Biosci. Bioeng.
, vol.112
, Issue.6
, pp. 606-610
-
-
Jazini, M.1
Herwig, C.2
-
24
-
-
10844293485
-
Characterization of the metabolic burden on Escherichia coli DH1 cells imposed by the presence of a plasmid containing a gene therapy sequence
-
Rozkov, A.; Avignone-Rossa, C. A.; Ertl, P. F.; Jones, P.; O'Kennedy, R. D.; Smith, J. J.; Dale, J. W.; Bushell, M. E. Characterization of the metabolic burden on Escherichia coli DH1 cells imposed by the presence of a plasmid containing a gene therapy sequence. Biotechnol. Bioeng. 2004, 88 (7), 909 -915.
-
(2004)
Biotechnol. Bioeng.
, vol.88
, Issue.7
, pp. 909-915
-
-
Rozkov, A.1
Avignone-Rossa, C.A.2
Ertl, P.F.3
Jones, P.4
O'Kennedy, R.D.5
Smith, J.J.6
Dale, J.W.7
Bushell, M.E.8
-
25
-
-
79952100002
-
A dynamic method based on the specific substrate uptake rate to set up a feeding strategy for Pichia pastoris
-
Dietzsch, C.; Spadiut, O.; Herwig, C. A dynamic method based on the specific substrate uptake rate to set up a feeding strategy for Pichia pastoris. Microb. Cell Fact. 2011, 10, 14.
-
(2011)
Microb. Cell Fact.
, vol.10
, pp. 14
-
-
Dietzsch, C.1
Spadiut, O.2
Herwig, C.3
-
26
-
-
80054905919
-
A fast approach to determine a fed batch feeding profile for recombinant Pichia pastoris strains
-
Dietzsch, C.; Spadiut, O.; Herwig, C. A fast approach to determine a fed batch feeding profile for recombinant Pichia pastoris strains. Microb. Cell Fact. 2011, 10, 85.
-
(2011)
Microb. Cell Fact.
, vol.10
, pp. 85
-
-
Dietzsch, C.1
Spadiut, O.2
Herwig, C.3
-
27
-
-
84870356622
-
Efficient feeding profile optimization using physiological information
-
in press
-
Wechselberger, P.; Sagmeister, P.; Engelking, H.; Schmidt, T.; Wenger, J. Efficient feeding profile optimization using physiological information. Bioprocess Biosyst. Eng. 2012, in press.
-
(2012)
Bioprocess Biosyst. Eng.
-
-
Wechselberger, P.1
Sagmeister, P.2
Engelking, H.3
Schmidt, T.4
Wenger, J.5
-
28
-
-
0037955821
-
Generally applicable fed-batch culture concept based on the detection of metabolic state by on-line balancing
-
Jobé, A. M.; Herwig, C.; Surzyn, M.; Walker, B.; Marison, I.; von Stockar, U. Generally applicable fed-batch culture concept based on the detection of metabolic state by on-line balancing. Biotechnol. Bioeng. 2003, 82 (6), 627- 639.
-
(2003)
Biotechnol. Bioeng.
, vol.82
, Issue.6
, pp. 627-639
-
-
Jobé, A.M.1
Herwig, C.2
Surzyn, M.3
Walker, B.4
Marison, I.5
Von Stockar, U.6
-
29
-
-
0035917935
-
High-cell-density fermentation for production of L-N-carbamoylase using an expression system based on the Escherichia coli rhaBAD promoter
-
Wilms, B.; Hauck, A.; Reuss, M.; Syldatk, C.; Mattes, R.; Siemann, M.; Altenbuchner, J. High-cell-density fermentation for production of L-N-carbamoylase using an expression system based on the Escherichia coli rhaBAD promoter. Biotechnol. Bioeng. 2001, 73 (2), 95-103.
-
(2001)
Biotechnol. Bioeng.
, vol.73
, Issue.2
, pp. 95-103
-
-
Wilms, B.1
Hauck, A.2
Reuss, M.3
Syldatk, C.4
Mattes, R.5
Siemann, M.6
Altenbuchner, J.7
-
30
-
-
8344256552
-
Recombinant protein folding and misfolding in Escherichia coli
-
Baneyx, F.; Mujacic, M. Recombinant protein folding and misfolding in Escherichia coli. Nat. Biotechnol. 2004, 22 (11), 1399 -1408.
-
(2004)
Nat. Biotechnol.
, vol.22
, Issue.11
, pp. 1399-1408
-
-
Baneyx, F.1
Mujacic, M.2
-
31
-
-
0029927276
-
Impact of plasmid presence and induction on cellular responses in fed batch cultures of Escherichia coli
-
Andersson, L.; Yang, S.; Neubauer, P.; Enfors, S. O. Impact of plasmid presence and induction on cellular responses in fed batch cultures of Escherichia coli. J. Biotechnol. 1996, 46 (3), 255-263.
-
(1996)
J. Biotechnol.
, vol.46
, Issue.3
, pp. 255-263
-
-
Andersson, L.1
Yang, S.2
Neubauer, P.3
Enfors, S.O.4
-
32
-
-
0034065261
-
Extracellular expression, purification, and characterization of a
-
winter flounder antifreeze polypeptide from Escherichia coli
-
Tong, L. Extracellular expression, purification, and characterization of a winter flounder antifreeze polypeptide from Escherichia coli. Protein Expr. Purif. 2000, 18 (2), 175-181.
-
(2000)
Protein Expr. Purif.
, vol.18
, Issue.2
, pp. 175-181
-
-
Tong, L.1
-
33
-
-
0035002525
-
Cell lysis in Escherichia coli cultures stimulates growth and biosynthesis of recombinant proteins in surviving cells
-
Corchero, J. L.; Cubarsí, R.; Vila, P.; Arís, A.; Villaverde, A. Cell lysis in Escherichia coli cultures stimulates growth and biosynthesis of recombinant proteins in surviving cells. Microbiol. Res. 2001, 156 (1), 13-18.
-
(2001)
Microbiol. Res.
, vol.156
, Issue.1
, pp. 13-18
-
-
Corchero, J.L.1
Cubarsí, R.2
Vila, P.3
Arís, A.4
Villaverde, A.5
-
34
-
-
77049098063
-
Efficient production of extracellular proteins with Escherichia coli by means of optimized coexpression of bacteriocin release proteins
-
Sommer, B.; Friehs, K.; Flaschel, E. Efficient production of extracellular proteins with Escherichia coli by means of optimized coexpression of bacteriocin release proteins. J. Biotechnol. 2010, 145 (4), 350 -358.
-
(2010)
J. Biotechnol.
, vol.145
, Issue.4
, pp. 350-358
-
-
Sommer, B.1
Friehs, K.2
Flaschel, E.3
-
35
-
-
0030088492
-
Cell segregation and lysis have profound effects on the growth of Escherichia coli in high cell density fed batch cultures
-
Andersson, L.; Strandberg, L.; Enfors, S.-O. Cell segregation and lysis have profound effects on the growth of Escherichia coli in high cell density fed batch cultures. Biotechnol. Prog. 1996, 12 (2), 190 -195.
-
(1996)
Biotechnol. Prog.
, vol.12
, Issue.2
, pp. 190-195
-
-
Andersson, L.1
Strandberg, L.2
Enfors, S.-O.3
-
36
-
-
12244259063
-
Limiting factors in Escherichia coli fed-batch production of recombinant proteins
-
Sandén, A. M.; Prytz, I.; Tubulekas, I.; Förberg, C.; Le, H.; Hektor, A.; Neubauer, P.; Pragai, Z.; Harwood, C.; Ward, A.; Picon, A.; De Mattos, J. T.; Postma, P.; Farewell, A.; Nyström, T.; Reeh, S.; Pedersen, S.; Larsson, G. Limiting factors in Escherichia coli fed-batch production of recombinant proteins. Biotechnol. Bioeng. 2003, 81 (2), 158 -166.
-
(2003)
Biotechnol. Bioeng.
, vol.81
, Issue.2
, pp. 158-166
-
-
Sandén, A.M.1
Prytz, I.2
Tubulekas, I.3
Förberg, C.4
Le, H.5
Hektor, A.6
Neubauer, P.7
Pragai, Z.8
Harwood, C.9
Ward, A.10
Picon, A.11
De Mattos, J.T.12
Postma, P.13
Farewell, A.14
Nyström, T.15
Reeh, S.16
Pedersen, S.17
Larsson, G.18
-
37
-
-
0028801765
-
Metabolic load and heterologous gene expression
-
Glick, B. R. Metabolic load and heterologous gene expression. Biotechnol. Adv. 1995, 13 (2), 247-261.
-
(1995)
Biotechnol. Adv.
, vol.13
, Issue.2
, pp. 247-261
-
-
Glick, B.R.1
-
38
-
-
0026416683
-
Plasmid presence changes the relative levels of many host cell proteins and ribosome components in recombinant Escherichia coli
-
Birnbaum, S.; Bailey, J. E. Plasmid presence changes the relative levels of many host cell proteins and ribosome components in recombinant Escherichia coli. Biotechnol. Bioeng. 1991, 37 (8), 736 -745.
-
(1991)
Biotechnol. Bioeng.
, vol.37
, Issue.8
, pp. 736-745
-
-
Birnbaum, S.1
Bailey, J.E.2
-
39
-
-
0018867283
-
Guanosine-5″-diphosphate-3″-diphosphate (ppGpp) and the regulation of protein breakdown in Escherichia coli
-
Voellmy, R.; Goldberg, A. L. Guanosine-5″-diphosphate-3″- diphosphate (ppGpp) and the regulation of protein breakdown in Escherichia coli. J. Biol. Chem. 1980, 255 (3), 1008 -1014.
-
(1980)
J. Biol. Chem.
, vol.255
, Issue.3
, pp. 1008-1014
-
-
Voellmy, R.1
Goldberg, A.L.2
-
40
-
-
0031721651
-
Effect of temperature on in vivo protein synthetic capacity in Escherichia coli
-
Farewell, A.; Neidhardt, F. C. Effect of temperature on in vivo protein synthetic capacity in Escherichia coli. J. Bacteriol. 1998, 180 (17), 4704-4710.
-
(1998)
J. Bacteriol.
, vol.180
, Issue.17
, pp. 4704-4710
-
-
Farewell, A.1
Neidhardt, F.C.2
-
41
-
-
77955852809
-
On-line infrared spectroscopy for bioprocess monitoring
-
Landgrebe, D.; Haake, C.; Höpfner, T.; Beutel, S.; Hitzmann, B.; Scheper, T.; Rhiel, M.; Reardon, K. F. On-line infrared spectroscopy for bioprocess monitoring. Appl. Microbiol. Biotechnol. 2010, 88 (1), 11-22.
-
(2010)
Appl. Microbiol. Biotechnol.
, vol.88
, Issue.1
, pp. 11-22
-
-
Landgrebe, D.1
Haake, C.2
Höpfner, T.3
Beutel, S.4
Hitzmann, B.5
Scheper, T.6
Rhiel, M.7
Reardon, K.F.8
-
42
-
-
84874287540
-
On-line multiple component analysis for efficient quantitative bioprocess development
-
in press
-
C. Dietzsch, O. Spadiut, C. Herwig, On-line multiple component analysis for efficient quantitative bioprocess development. J. Biotechnol. 2012, in press.
-
(2012)
J. Biotechnol.
-
-
Dietzsch, C.1
Spadiut, O.2
Herwig, C.3
|