Establishment of Operating Ranges in a Purification Process for a Monoclonal Antibody

ACS Symposium Series

Volumn 698, Issue , 1998, Pages 80-92

  Smith, Thomas M ^a   Wilson, Eileen ^a   Scott, Robert G ^a   Misczak, John W ^a   Bodek, John M ^a   Zabriskie, Dane W ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0346544531     PISSN: 00976156     EISSN: None     Source Type: Book Series    
DOI: 10.1021/bk-1998-0698.ch007     Document Type: Article

References (2)

1. U.S. Food and Drug Administration; Guideline on General Principles of Process Validation 1987.
2. CPMP/ICH/295/95 Consensus Guideline; Quality of Biotechnology Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; Geneva, Switzerland, 1997.