메뉴 건너뛰기




Volumn 7, Issue 10, 2012, Pages 1256-1268

Strategic Assay Selection for analytics in high-throughput process development: Case studies for downstream processing of monoclonal antibodies

Author keywords

Analytical bottleneck; HTPD; MAb; Multicriteria decision making

Indexed keywords

ANALYTES; ANALYTICAL BOTTLENECK; ANALYTICAL METHOD; BIOPROCESS DEVELOPMENT; DOWNSTREAM-PROCESSING; HIGH-THROUGHPUT; HTPD; MAB; MULTI CRITERIA DECISION MAKING; PROCESS DEVELOPMENT; PURIFICATION PROCESS; STOCHASTIC RANKING;

EID: 84867216317     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.201100476     Document Type: Article
Times cited : (9)

References (32)
  • 1
    • 60149106150 scopus 로고    scopus 로고
    • Quality by design for biopharmaceuticals.
    • Rathore, A. S., 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
  • 2
    • 45149083380 scopus 로고    scopus 로고
    • High-throughput process development: Determination of dynamic binding capacity using microtiter filter plates filled with chromatography resin.
    • Bergander, T., Nilsson-Välimaa, K., Öberg, K., Lacki, K. M., High-throughput process development: Determination of dynamic binding capacity using microtiter filter plates filled with chromatography resin. Biotechnol. Prog. 2008, 24, 632-639.
    • (2008) Biotechnol. Prog. , vol.24 , pp. 632-639
    • Bergander, T.1    Nilsson-Välimaa, K.2    Öberg, K.3    Lacki, K.M.4
  • 3
    • 46249100489 scopus 로고    scopus 로고
    • High-throughput screening of chromatographic separations: IV. Ion-exchange.
    • Kelley, B. D., Switzer, M., Bastek, P., Kramarczyk, J. F. et al., High-throughput screening of chromatographic separations: IV. Ion-exchange. Biotechnol. Bioeng. 2008, 100, 950-963.
    • (2008) Biotechnol. Bioeng. , vol.100 , pp. 950-963
    • Kelley, B.D.1    Switzer, M.2    Bastek, P.3    Kramarczyk, J.F.4
  • 4
    • 46249099122 scopus 로고    scopus 로고
    • High-throughput screening of chromatographic separations: II. Hydrophobic interaction.
    • Kramarczyk, J. F., Kelley, B. D., Coffman, J. L., High-throughput screening of chromatographic separations: II. Hydrophobic interaction. Biotechnol. Bioeng. 2008, 100, 707-720.
    • (2008) Biotechnol. Bioeng. , vol.100 , pp. 707-720
    • Kramarczyk, J.F.1    Kelley, B.D.2    Coffman, J.L.3
  • 5
    • 46249087945 scopus 로고    scopus 로고
    • High-throughput screening of chromatographic separations: III. Monoclonal antibodies on ceramic hydroxyapatite.
    • Wensel, D. L., Kelley, B. D., Coffman, J. L., High-throughput screening of chromatographic separations: III. Monoclonal antibodies on ceramic hydroxyapatite. Biotechnol. Bioeng. 2008, 100, 839-854.
    • (2008) Biotechnol. Bioeng. , vol.100 , pp. 839-854
    • Wensel, D.L.1    Kelley, B.D.2    Coffman, J.L.3
  • 6
    • 28244461283 scopus 로고    scopus 로고
    • High throughput screening of chromatographic phases for rapid process development.
    • Bensch, M., Schulze Wierling, P., von Lieres, E., Hubbuch, J., High throughput screening of chromatographic phases for rapid process development. Chem. Eng. Technol. 2005, 28, 1274-1284.
    • (2005) Chem. Eng. Technol. , vol.28 , pp. 1274-1284
    • Bensch, M.1    Schulze Wierling, P.2    von Lieres, E.3    Hubbuch, J.4
  • 7
    • 46249092863 scopus 로고    scopus 로고
    • High-throughput screening of chromatographic seperations: I. Method development and column modelling.
    • Coffman, J. L., Karmarczyk, J. F., Kelley, B. D., High-throughput screening of chromatographic seperations: I. Method development and column modelling. Biotechnol. Bioeng. 2008, 100, 605-618.
    • (2008) Biotechnol. Bioeng. , vol.100 , pp. 605-618
    • Coffman, J.L.1    Karmarczyk, J.F.2    Kelley, B.D.3
  • 8
    • 0037212099 scopus 로고    scopus 로고
    • Accelerated design of bioconversion processes using automated microscale processing techniques.
    • Lye, G. J., Ayazi-Shamlou, P., Baganz, F., Dalby, P. A. et al., Accelerated design of bioconversion processes using automated microscale processing techniques. Trends Biotechnol. 2003, 21, 29-37.
    • (2003) Trends Biotechnol. , vol.21 , pp. 29-37
    • Lye, G.J.1    Ayazi-Shamlou, P.2    Baganz, F.3    Dalby, P.A.4
  • 9
    • 84864853519 scopus 로고    scopus 로고
    • The hybrid experimental simplex algorithm - An alternative method 'sweet spot' identification in early bioprocess development: Case studies in ion exchange chromatography.
    • Konstantinidis, S., Chhatre, S., Velayudhan, A., Heldin, E., Titchener-Hooker, N., The hybrid experimental simplex algorithm - An alternative method 'sweet spot' identification in early bioprocess development: Case studies in ion exchange chromatography. Anal. Chim. Acta 2012, 743, 19-32.
    • (2012) Anal. Chim. Acta , vol.743 , pp. 19-32
    • Konstantinidis, S.1    Chhatre, S.2    Velayudhan, A.3    Heldin, E.4    Titchener-Hooker, N.5
  • 10
    • 60849096390 scopus 로고    scopus 로고
    • High throughput screening for the design and optimization of chromatographic processes: Automated optimization of chromatohraphic phase systems.
    • Susanto, A., Treier, K., Knieps-Grünhagen, E., von Lieres, E. et al., High throughput screening for the design and optimization of chromatographic processes: Automated optimization of chromatohraphic phase systems. Chem. Eng. Technol. 2009, 32, 140-154.
    • (2009) Chem. Eng. Technol. , vol.32 , pp. 140-154
    • Susanto, A.1    Treier, K.2    Knieps-Grünhagen, E.3    von Lieres, E.4
  • 11
    • 67650911692 scopus 로고    scopus 로고
    • Review: Microscale methods for high-throughput chromatography development in the pharmaceutical industry.
    • Chhatre, S., Titchener-Hooker, N. J., Review: Microscale methods for high-throughput chromatography development in the pharmaceutical industry. J. Chem. Technol. Biotechnol. 2009, 84, 927-940.
    • (2009) J. Chem. Technol. Biotechnol. , vol.84 , pp. 927-940
    • Chhatre, S.1    Titchener-Hooker, N.J.2
  • 12
    • 84867233278 scopus 로고    scopus 로고
    • US Food and Drug Administration, Guidance for industry: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, FDA, Rockville, MD, August.
    • US Food and Drug Administration, Guidance for industry: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, FDA, Rockville, MD, August 1999.
    • (1999)
  • 13
    • 0025832648 scopus 로고
    • Preparation of clinical grade monoclonal antibodies from serum-containing cell culture supernatants.
    • Jiskoot, W., van Hertrooij, J. J., Hoven, A. M., Klein Gebbinck, J. W. et al., Preparation of clinical grade monoclonal antibodies from serum-containing cell culture supernatants. J. Immunol. Methods 1991, 138, 273-283.
    • (1991) J. Immunol. Methods , vol.138 , pp. 273-283
    • Jiskoot, W.1    van Hertrooij, J.J.2    Hoven, A.M.3    Klein Gebbinck, J.W.4
  • 14
    • 0037377310 scopus 로고    scopus 로고
    • Design and scaleup of downstream processing of monoclonal antibodies for cancer therapy: From research to clinical proof of principle.
    • Horenstein, A. L., Crivellin, F., Funaro, A., Said, M. et al., Design and scaleup of downstream processing of monoclonal antibodies for cancer therapy: From research to clinical proof of principle. J. Immunol. Methods 2003, 275, 99-112.
    • (2003) J. Immunol. Methods , vol.275 , pp. 99-112
    • Horenstein, A.L.1    Crivellin, F.2    Funaro, A.3    Said, M.4
  • 15
    • 33749364369 scopus 로고    scopus 로고
    • Shear stress analysis of mammalian cell suspensions for prediction of industrial centrifugation and its verification.
    • Hutchinson, N., Bingham, N., Murell, N., Farid, S. et al., Shear stress analysis of mammalian cell suspensions for prediction of industrial centrifugation and its verification. Biotechnol. Bioeng. 2006, 95, 483-491.
    • (2006) Biotechnol. Bioeng. , vol.95 , pp. 483-491
    • Hutchinson, N.1    Bingham, N.2    Murell, N.3    Farid, S.4
  • 16
    • 48649097549 scopus 로고    scopus 로고
    • Weak partitioning chromatography for anion exchange purification of monoclonal antibodies.
    • Kelley, B. D., Tobler, S. A., Brown, P., Coffman, J. L. et al., Weak partitioning chromatography for anion exchange purification of monoclonal antibodies. Biotechnol. Bioeng. 2008, 101, 553-566.
    • (2008) Biotechnol. Bioeng. , vol.101 , pp. 553-566
    • Kelley, B.D.1    Tobler, S.A.2    Brown, P.3    Coffman, J.L.4
  • 17
    • 33847690744 scopus 로고    scopus 로고
    • Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal.
    • Stein, A., Kiesewetter, A., Cation exchange chromatography in antibody purification: pH screening for optimised binding and HCP removal. J. Chromatogr., B Analyt. Technol. Biomed. Life Sci. 2007, 848, 151-158.
    • (2007) J. Chromatogr., B Analyt. Technol. Biomed. Life Sci. , vol.848 , pp. 151-158
    • Stein, A.1    Kiesewetter, A.2
  • 20
    • 23244444983 scopus 로고    scopus 로고
    • Combining multiple quantitative and qualitative goals when assessing biomanufacturing strategies under uncertainty.
    • Farid, S. S., Washbrook, J., Titchener-Hooker, N. J., Combining multiple quantitative and qualitative goals when assessing biomanufacturing strategies under uncertainty. Biotechnol. Prog. 2005, 21, 1183-1191.
    • (2005) Biotechnol. Prog. , vol.21 , pp. 1183-1191
    • Farid, S.S.1    Washbrook, J.2    Titchener-Hooker, N.J.3
  • 23
    • 65549124409 scopus 로고    scopus 로고
    • Host cell proteins in biologics development: Identification, quantitation and risk assessment.
    • Wang, X., Hunter, A. K., Mozier, N. M., Host cell proteins in biologics development: Identification, quantitation and risk assessment. Biotechnol. Bioeng. 2009, 103, 446-458.
    • (2009) Biotechnol. Bioeng. , vol.103 , pp. 446-458
    • Wang, X.1    Hunter, A.K.2    Mozier, N.M.3
  • 25
    • 38049143550 scopus 로고    scopus 로고
    • Aggregation analysis of therapeutic proteins, part 2 analytical ultracentrifugation and dynamic light scattering.
    • Arakawa, T., Philo, J. S., Ejima, D., Tsumoto, K. et al., Aggregation analysis of therapeutic proteins, part 2 analytical ultracentrifugation and dynamic light scattering. BioProcess Int. 2007, 5, 36-47.
    • (2007) BioProcess Int. , vol.5 , pp. 36-47
    • Arakawa, T.1    Philo, J.S.2    Ejima, D.3    Tsumoto, K.4
  • 26
    • 33745612946 scopus 로고    scopus 로고
    • Electrophoresis of pharmaceutical proteins: Status quo.
    • Little, M. J., Paquette, D. M., Roos, P. K., Electrophoresis of pharmaceutical proteins: Status quo. Electrophoresis 2006, 27, 2477-2485.
    • (2006) Electrophoresis , vol.27 , pp. 2477-2485
    • Little, M.J.1    Paquette, D.M.2    Roos, P.K.3
  • 27
    • 0000372281 scopus 로고
    • A preference ranking organisation method (The PROMETHEE Method for Multiple Criteria Decision-Making).
    • Brans, J. P., Vincke, P. H., A preference ranking organisation method (The PROMETHEE Method for Multiple Criteria Decision-Making). Manage. Sci. 1985, 31, 647-656.
    • (1985) Manage. Sci. , vol.31 , pp. 647-656
    • Brans, J.P.1    Vincke, P.H.2
  • 28
    • 0020702683 scopus 로고
    • How to select and how to rank projects: The PROMETHEE method.
    • Brans, J. P., Vincke, P. H., Mareschal, B., How to select and how to rank projects: The PROMETHEE method. Eur. J. Oper. Res. 1986, 24, 228-238.
    • (1986) Eur. J. Oper. Res. , vol.24 , pp. 228-238
    • Brans, J.P.1    Vincke, P.H.2    Mareschal, B.3
  • 29
    • 33746512815 scopus 로고    scopus 로고
    • Incorporating uncertainty in the PROMETHEE MCDA method.
    • Hyde, K., Maier, H. R., Colby, C., Incorporating uncertainty in the PROMETHEE MCDA method. J. Multi-Crit. Decis. Anal. 2003, 12, 245-259.
    • (2003) J. Multi-Crit. Decis. Anal. , vol.12 , pp. 245-259
    • Hyde, K.1    Maier, H.R.2    Colby, C.3
  • 31
    • 4444231656 scopus 로고    scopus 로고
    • Comparison of selected analytical techniques for protein sizing, quantitation and molecular weight determination.
    • Goetz, H., Kuschel, M., Wulff, T., Sauber, C. et al., Comparison of selected analytical techniques for protein sizing, quantitation and molecular weight determination. J. Biochem. Biophys. Methods 2004, 60, 281-293.
    • (2004) J. Biochem. Biophys. Methods , vol.60 , pp. 281-293
    • Goetz, H.1    Kuschel, M.2    Wulff, T.3    Sauber, C.4
  • 32
    • 84878406536 scopus 로고    scopus 로고
    • Miller, J. M., Crowther, J. B. (Ed.), Analytical Chemistry in a GMP Environment: A Practical Guide, John Wiley & Sons, New York
    • Crowther, J. B., Lauwers, W., Adusumalli, S., Shenbagamurthi, P., in: Miller, J. M., Crowther, J. B. (Ed.), Analytical Chemistry in a GMP Environment: A Practical Guide, John Wiley & Sons, New York 2000 pp. 5-12.
    • (2000) , pp. 5-12
    • Crowther, J.B.1    Lauwers, W.2    Adusumalli, S.3    Shenbagamurthi, P.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.