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Volumn 23, Issue 9, 2010, Pages 26-36

Design space development for lyophilization using Doe and process modeling

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

EID: 78650324206     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article
Times cited : (34)

References (15)
  • 1
    • 68749083515 scopus 로고    scopus 로고
    • A roadmap for implementation of quality by design (QbD) for biotechnology products
    • Rathore AS. A roadmap for implementation of Quality by Design (QbD) for biotechnology products. Trends Biotechnol. 2009;27(9):546-53.
    • (2009) Trends Biotechnol. , vol.27 , Issue.9 , pp. 546-553
    • Rathore, A.S.1
  • 2
    • 78650375505 scopus 로고    scopus 로고
    • US Food and Drug Administration, Pharmaceutical development. Rockville, MD; Nov
    • US Food and Drug Administration. Guidance for industry. Q8 (R2). Pharmaceutical development. Rockville, MD; Nov. 2009.
    • (2009) Guidance for Industry. Q8 (R2)
  • 3
    • 77954914066 scopus 로고    scopus 로고
    • Characterization of a monoclonal antibody cell culture production process using a quality by design approach
    • Horvath B, Mun M, Laird MW. Characterization of a monoclonal antibody cell culture production process using a quality by design approach. Mol Biotechnol. 2010;45(3):203-6.
    • (2010) Mol. Biotechnol. , vol.45 , Issue.3 , pp. 203-206
    • Horvath, B.1    Mun, M.2    Laird, M.W.3
  • 4
    • 77958542825 scopus 로고    scopus 로고
    • Application of quality by design and risk assessment principles for the development of formulation design space
    • Rathore AS, Mhatre R, editors, Hoboken, NJ: John Wiley & Sons
    • Ng K, Rajagopalan N. Application of quality by design and risk assessment principles for the development of formulation design space. In: Rathore AS, Mhatre R, editors. Quality by design for biopharmaceuticals: perspectives and case studies. Hoboken, NJ: John Wiley & Sons; 2009.
    • (2009) Quality by Design for Biopharmaceuticals: Perspectives and Case Studies
    • Ng, K.1    Rajagopalan, N.2
  • 5
    • 54949102425 scopus 로고    scopus 로고
    • Quality-bydesign (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 LL, Lyon RC, Khan MA, Hussain AS, Hoag SW. Quality-bydesign (QbD): Effects of testing parameters and formulation variables on the segregation tendency of pharmaceutical powder measured by the ASTM D 6940-04 segregation tester. J Pharm Sci. 2008;97(10):4485-97.
    • (2008) J. Pharm. Sci. , 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    Hussain, A.S.7    Hoag, S.W.8
  • 7
    • 0038033992 scopus 로고    scopus 로고
    • Weinheim, Germany: Wiley-VCH Verlag GmbH & Co.
    • Oetjen GW, Haseley P. Freeze-drying. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co.; 2004.
    • (2004) Freeze-drying
    • Oetjen, G.W.1    Haseley, P.2
  • 9
    • 0029047050 scopus 로고
    • Development of an efficient single-step freeze-drying cycle for protein formulations
    • Chang BS, Fischer NL. Development of an efficient single-step freeze-drying cycle for protein formulations. Pharm Res. 1995;12(6):831-7.
    • (1995) Pharm. Res. , vol.12 , Issue.6 , pp. 831-837
    • Chang, B.S.1    Fischer, N.L.2
  • 10
    • 78650337067 scopus 로고    scopus 로고
    • IBC USA conferences Inc. A holistic approach to drug product process characterization and validation for a monoclonal antibody using QbD concepts
    • Carlsbad, CA, Mar. 1-2
    • Lim F, Martin-Moe, S, Sane SU. IBC USA Conferences Inc. A holistic approach to drug product process characterization and validation for a monoclonal antibody using QbD concepts. Process and Product Validation Event. Carlsbad, CA. 2010 Mar. 1-2.
    • (2010) Process and Product Validation Event
    • Lim, F.1    Martin-Moe, S.2    Sane, S.U.3
  • 11
    • 39149134333 scopus 로고    scopus 로고
    • Elements of quality by design in development of freeze-dried parenterals
    • Nail, SL, Searles JA. Elements of quality by design in development of freeze-dried parenterals, BioPharm Int. 2008;21(1):44-52.
    • (2008) BioPharm Int. , vol.21 , Issue.1 , pp. 44-52
    • Nail, S.L.1    Searles, J.A.2
  • 12
    • 78650357014 scopus 로고    scopus 로고
    • Considerations for successful lyophilization process scale-up, technology transfer and routine production
    • Jameel F, Hershenson S, editors, Hoboken, NJ: John Wiley & Sons, Inc.
    • Sane SU, Hsu CC. Considerations for successful lyophilization process scale-up, technology transfer and routine production. In: Jameel F, Hershenson S, editors. Formulation and process development strategies for manufacturing biopharmaceuticals. Hoboken, NJ: John Wiley & Sons, Inc.; 2010.
    • (2010) Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
    • Sane, S.U.1    Hsu, C.C.2
  • 13
    • 78650315182 scopus 로고    scopus 로고
    • A mathematical model for a large-scale freeze-drying process: A tool for process development & efficient production
    • Hyderabad, India
    • Sane SU, Hsu CC. A mathematical model for a large-scale freeze-drying process: a tool for process development & efficient production. Proceedings of 16th International Drying Symposium, Hyderabad, India. 2008; pp. 680-8.
    • (2008) Proceedings of 16th International Drying Symposium , pp. 680-688
    • Sane, S.U.1    Hsu, C.C.2
  • 14
    • 0032791527 scopus 로고    scopus 로고
    • Lyophilization of protein formulations in vials: Investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse
    • Overcashier DE, Patapoff TW, Hsu CC. Lyophilization of protein formulations in vials: Investigation of the relationship between resistance to vapor flow during primary drying and small-scale product collapse. J Pharm Sci. 1999;88(7):688-95.
    • (1999) J. Pharm. Sci. , vol.88 , Issue.7 , pp. 688-695
    • Overcashier, D.E.1    Patapoff, T.W.2    Hsu, C.C.3
  • 15
    • 0020596449 scopus 로고
    • Physical chemistry of freeze-drying: Measurement of sublimation rates for frozen aqueous solutions by microbalance technique
    • Pikal MJ, Shah S, Senior D, Lang JE. Physical chemistry of freeze-drying: measurement of sublimation rates for frozen aqueous solutions by microbalance technique. J Pharm Sci. 1983;72(6):635-50.
    • (1983) J. Pharm. Sci. , vol.72 , Issue.6 , pp. 635-650
    • Pikal, M.J.1    Shah, S.2    Senior, D.3    Lang, J.E.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.