Worst-Case Approach to Validation of Operating Ranges

ACS Symposium Series

Volumn 698, Issue , 1998, Pages 69-79

  Gardner, Alan R ^a   Smith, Thomas M ^a   Gerber, Robert G ^a   Zabriskie, Dane W ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0347804791     PISSN: 00976156     EISSN: None     Source Type: Book Series    
DOI: 10.1021/bk-1998-0698.ch006     Document Type: Article

References (8)

1. Chapman, K. G. Pharmaceutical Technol. 1991, 15, pp. 92-96.
2. US Food and Drug Administration Guideline on General Principles of Process Validation, 1987.
3. Kelly, B. D.; Jennings, P.; Wright, R.; Briasco, C. BioPharm 1997, 10, pp. 36-47.
4. Smith, T.; Bodek, J.; Misczak, J.; Scott, R.; Wilson, E.; Zabriskie, D. "Establishment of Operating Ranges in a Purification Process for a Monoclonal Antibody", Chapter 7 in this book.
5. Gerber, R.; McAllister, P.; Smith, C.; Zabriskie, D.; Gardner A. "Establishment of Acceptable Process Control Ranges for Production of a Monoclonal Antibody by Cultures of Recombinant CHO Cells", Chapter 4 in this book.
6. Gardner, A; Gerber, R.; Smith, C.; Strohsacker, M.; McAllister, P.; Zabriskie, D. "Use of Scale-Down Models in Validation of Processes for Production of Recombinant Biopharmaceuticals", ACS 211th National Meeting, 1996.
7. Jacobson, F.; Hanson, T.; Wong, P.; Mulkerrin, M.; Deveney, J.; Reilly, D.; Wong, S. J. Chromatogr. 1997, 763, pp. 31-48.
8. Mulkerrin, M. "A Comprehensive Strategy for the Characterization of a Monoclonal Antibody", Waterside Monoclonal Conference, 1997.