메뉴 건너뛰기




Volumn 66, Issue 6, 2012, Pages 526-541

Information processing: Rate-based investigation of cell physiological changes along design space development

Author keywords

Data processing; Design of experiments; Design space development; Information processing; Multivariate data analysis; Process development; Process optimization; Quality by design

Indexed keywords

CARBON DIOXIDE; PROTEIN;

EID: 84873662135     PISSN: 10797440     EISSN: 19482124     Source Type: Journal    
DOI: 10.5731/pdajpst.2012.00889     Document Type: Article
Times cited : (20)

References (42)
  • 1
    • 79951920084 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 13
    • 68749083515 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 18
    • 77956443855 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 28
    • 0037955821 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 37
    • 0028801765 scopus 로고
    • 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 scopus 로고
    • 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 scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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
  • 42
    • 84874287540 scopus 로고    scopus 로고
    • 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.