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Volumn , Issue , 2012, Pages 455-490

Validation of the Zevalin® Purification Process: A Case Study

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EID: 84979151055     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b12013-21     Document Type: Chapter
Times cited : (1)

References (18)
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    • Worst Case Approach to Validating Operation Ranges
    • ACS Symp. Ser. No. 698. Edited by B. Kelly and A. Ramelmeir. Washington, DC: ACS Books
    • Gardner, A., T. Smith, R. Gerber, and D. Zabriskie. “Worst Case Approach to Validating Operation Ranges.” In Validation of Bio-pharmaceuticals Manufacturing Processes, ACS Symp. Ser. No. 698. Edited by B. Kelly and A. Ramelmeir. Washington, DC: ACS Books, 69-79.
    • Validation of Bio-pharmaceuticals Manufacturing Processes , pp. 69-79
    • Gardner, A.1    Smith, T.2    Gerber, R.3    Zabriskie, D.4
  • 6
    • 85055586098 scopus 로고    scopus 로고
    • Establishment of Operating Ranges in a Purification Process for a Monoclonal Antibody
    • ACS Symp. Ser. No. 698. Edited by B. Kelly and A. Ramelmeir. Washington, DC: ACS Books
    • Smith, T., E. Wilson, R. Scott, J. Misczak, J. Bodek, and D. Zabriskie. “Establishment of Operating Ranges in a Purification Process for a Monoclonal Antibody.” In Validation of Biopharmaceuticals Manufacturing Processes, ACS Symp. Ser. No. 698. Edited by B. Kelly and A. Ramelmeir. Washington, DC: ACS Books, 80-92.
    • Validation of Biopharmaceuticals Manufacturing Processes , pp. 80-92
    • Smith, T.1    Wilson, E.2    Scott, R.3    Misczak, J.4    Bodek, J.5    Zabriskie, D.6
  • 9
    • 0036229888 scopus 로고    scopus 로고
    • Validation of Biopharmaceutical Purification Process for Viral Clearance Evaluation
    • May
    • Darling, A. “Validation of Biopharmaceutical Purification Process for Viral Clearance Evaluation.” Mol. Biotechnol., May 2002, 57-83.
    • (2002) Mol. Biotechnol , pp. 57-83
    • Darling, A.1
  • 12
    • 0030724305 scopus 로고    scopus 로고
    • WHO Expert Committee on Biological Standardization: Highlights of the Meeting of October 1996
    • Griffiths, E. “WHO Expert Committee on Biological Standardization: Highlights of the Meeting of October 1996.” Biologicals 25 (1997): 359-362.
    • (1997) Biologicals , vol.25 , pp. 359-362
    • Griffiths, E.1
  • 15
    • 85137470918 scopus 로고    scopus 로고
    • Technical Report No. 26, Sterilizing Filtration of Liquids
    • “Technical Report No. 26, Sterilizing Filtration of Liquids.” PDA J. Pharm. Sci. Technol., 2008, 52 (suppl.).
    • (2008) PDA J. Pharm. Sci. Technol , vol.52
  • 16
    • 0003092464 scopus 로고
    • Methodology for Analysis of Filter Extractables: A Model Solvent Approach
    • Stone, T., V. Goel, and J. Loszcak. Methodology for Analysis of Filter Extractables: A Model Solvent Approach.” Pharm. Technol. 18 (1994): 116-130.
    • (1994) Pharm. Technol , vol.18 , pp. 116-130
    • Stone, T.1    Goel, V.2    Loszcak, J.3
  • 17
    • 0030511839 scopus 로고    scopus 로고
    • Analysis and Evaluation of Filter Cartridge Extractables for Validation in Pharmaceutical Downstream Processing
    • Reif, O., P. Solkner, and J. Rupp. “Analysis and Evaluation of Filter Cartridge Extractables for Validation in Pharmaceutical Downstream Processing.” Pharm. Technol. 50 (1996): 399-410.
    • (1996) Pharm. Technol , vol.50 , pp. 399-410
    • Reif, O.1    Solkner, P.2    Rupp, J.3
  • 18
    • 0031005391 scopus 로고    scopus 로고
    • The Use of Model Solvents for Evaluating Extractables from Filters Used to Process Pharmaceutical Products
    • Weitzmen, C. “The Use of Model Solvents for Evaluating Extractables from Filters Used to Process Pharmaceutical Products.” Pharm. Technol. 10 (1997): 72-99.
    • (1997) Pharm. Technol , vol.10 , pp. 72-99
    • Weitzmen, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.