The roles of bioactivity assays in lot release and stability testing

BioProcess International

Volumn 8, Issue 6, 2010, Pages 33-42

  Rieder, Noel ^a   Gazzano Santoro, Hélène ^b   Schenerman, Mark ^c   Strause, Robert ^c   Fuchs, Chana ^d   Mire Sluis, Anthony ^a   McLeod, Lorna D ^c  

^a AMGEN INC   (United States)

^b GENENTECH INC   (United States)

^c MedImmune ^*

^d CDER   (United States)

Author keywords

Binding potency assays; Lot release; Stability; Surrogate assays

Indexed keywords

MONOCLONAL ANTIBODY;

ANTIGEN ANTIBODY REACTION; BINDING AFFINITY; BINDING ASSAY; BIOASSAY; BIOLOGICAL ACTIVITY; CELL ACTIVITY; CELL COUNT; CELL DENSITY; CELL GROWTH; CELL LINE; CELL MEDIATED CYTOTOXICITY; CELL VIABILITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG POTENCY; DRUG RELEASE; DRUG SCREENING; DRUG STABILITY; DRUG STRUCTURE; EFFECTOR CELL; ENZYME LINKED IMMUNOSORBENT ASSAY; FOOD AND DRUG ADMINISTRATION; GLYCOSYLATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIGAND BINDING; PERIPHERAL BLOOD MONONUCLEAR CELL; PHYSICOCHEMICAL MODEL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; STRUCTURE ACTIVITY RELATION; SURFACE PLASMON RESONANCE; TARGET CELL;

EID: 77955400039     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

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