Validation of large-scale chromatographic processes, Part 1: Case study of neuleze capture on Macroprep High-S

BioPharm

Volumn 15, Issue 5, 2002, Pages 16-20

  Breece, Timothy N ^a   Gilkerson, Ellen ^a   Schmelzer, Charles ^a  

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

REAGENT; RESIN;

ARTICLE; CHROMATOGRAPHY; CLEANING; CONTAMINATION; COST CONTROL; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; INSTRUMENT STERILIZATION; PROCESS CONTROL; RECYCLING; VALIDATION PROCESS; VIRAL CONTAMINATION;

EID: 0036255310     PISSN: 10408304     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (3)

1. Experimental design for validation of chromatographic process limits