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Volumn 45, Issue 3, 2010, Pages 203-206

Characterization of a monoclonal antibody cell culture production process using a quality by design approach

Author keywords

Chinese hamster ovary; Ion exchange chromatography; Monoclonal antibody; Process characterization; Process validation; Quality by Design

Indexed keywords

CHINESE HAMSTER OVARY; ION-EXCHANGE CHROMATOGRAPHY; PROCESS CHARACTERIZATION; PROCESS VALIDATION; QUALITY BY DESIGNS;

EID: 77954914066     PISSN: 10736085     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12033-010-9267-4     Document Type: Article
Times cited : (44)

References (7)
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    • A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma
    • Moran, E. B., McGowan, S. T., McGuire, J. M., Frankland, J. E., Oyebade, I. A., Waller, W., et al. (2000). A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma. Biotechnology and Bioengineering, 69(3), 242-255.
    • (2000) Biotechnology and Bioengineering , vol.69 , Issue.3 , pp. 242-255
    • Moran, E.B.1    McGowan, S.T.2    McGuire, J.M.3    Frankland, J.E.4    Oyebade, I.A.5    Waller, W.6
  • 3
    • 54949102425 scopus 로고    scopus 로고
    • Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester
    • Xie, L., Wu, H., Shen, M., Augsberger, L. L., Lyon, R. C., Khan, M. A., et al. (2008). Quality-by-design (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester. Journal of Pharmaceutical Sciences, 97(10), 4485-4497.
    • (2008) Journal of Pharmaceutical Sciences , vol.97 , Issue.10 , pp. 4485-4497
    • Xie, L.1    Wu, H.2    Shen, M.3    Augsberger, L.L.4    Lyon, R.C.5    Khan, M.A.6
  • 4
    • 33845586637 scopus 로고    scopus 로고
    • Can pharmaceutical process development become high tech?
    • McKenzie, P., Kiang, S., Tom, J., Rubin, A. E., & Futran, M. (2006). Can pharmaceutical process development become high tech? AIChE Journal, 52(12), 3990-3994.
    • (2006) AIChE Journal , vol.52 , Issue.12 , pp. 3990-3994
    • McKenzie, P.1    Kiang, S.2    Tom, J.3    Rubin, A.E.4    Futran, M.5
  • 6
    • 16344374566 scopus 로고    scopus 로고
    • Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed
    • Chaderjian, W. B., Chin, E. T., Harris, R. J., & Etcheverry, T. M. (2005). Effect of copper sulfate on performance of a serum-free CHO cell culture process and the level of free thiol in the recombinant antibody expressed. Biotechnology Progress, 21, 550-553.
    • (2005) Biotechnology Progress , Issue.21 , pp. 550-553
    • Chaderjian, W.B.1    Chin, E.T.2    Harris, R.J.3    Etcheverry, T.M.4
  • 7
    • 84889418037 scopus 로고    scopus 로고
    • Case study in definition of process design space for a microbial fermentation step
    • A. S. Rathore & R. Mhatre (Eds.), New York: Wiley
    • van Hoek, P., Harms, J., Wang, X., & Rathore, A. S. (2009) Case study in definition of process design space for a microbial fermentation step. In A. S. Rathore & R. Mhatre (Eds.), Quality by design for biopharmaceuticals (pp. 85-109) New York: Wiley.
    • (2009) Quality by Design for Biopharmaceuticals , pp. 85-109
    • Van Hoek, P.1    Harms, J.2    Wang, X.3    Rathore, A.S.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.