Process characterization and Design Space definition

Biologicals

Volumn 44, Issue 5, 2016, Pages 306-318

  Hakemeyer, Christian ^a   McKnight, Nathan ^b   St John, Rick ^b   Meier, Steven ^b   Trexler Schmidt, Melody ^b   Kelley, Brian ^b   Zettl, Frank ^a   Puskeiler, Robert ^c   Kleinjans, Annika ^a   Lim, Fred ^b   Wurth, Christine ^c  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

^b GENENTECH INC   (United States)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Design space; Monoclonal antibody; Process characterization; Process validation; Quality by design (QbD)

Indexed keywords

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ARTICLE; CONTROLLED STUDY; CRITICAL PROCESS PARAMETER; DESIGN SPACE; LIMIT OF QUANTITATION; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; PHYSICAL PARAMETERS; PRIORITY JOURNAL; PROCESS DESIGN; QUALITY BY DESIGN; RISK ASSESSMENT; VALIDATION PROCESS; ANIMAL; CHEMISTRY; GENETICS; HUMAN; IMMUNOLOGY; QUALITY CONTROL;

ANIMALS; ANTIBODIES, MONOCLONAL; HUMANS; QUALITY CONTROL; RECOMBINANT PROTEINS;

EID: 84979255600     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2016.06.004     Document Type: Article

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