A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma

Biotechnology and Bioengineering

Volumn 69, Issue 3, 2000, Pages 242-255

  Moran, Enda B ^a   McGowan, Steve T ^a   McGuire, John M ^a   Frankland, Janet E ^a   Oyebade, Israel A ^a   Waller, Wendy ^a   Archer, Linda C ^a   Morris, Lilla O ^a   Pandya, Jyoti ^a   Nathan, Samantha R ^a   Smith, Lee ^a   Cadette, Mervyn L ^a   Michalowski, Jurek T ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Antibody; Fed batch culture; Glycosylation; Process control parameters; Process validation; Statistical experimental design

Indexed keywords

BATCH CELL CULTURE; CHEMICAL REACTIONS; GROWTH KINETICS; PH EFFECTS; PROTEINS; TEMPERATURE;

GLYCOFORMS; GLYCOPROTEINS; GLYCOSYLATION; MURINE MYELOMA;

MONOCLONAL ANTIBODIES;

GLYCOPROTEIN; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN G1; MONOCLONAL ANTIBODY;

ANIMAL CELL; ANTIBODY PRODUCTION; ANTIBODY STRUCTURE; ARTICLE; CELL CULTURE; CONTROLLED STUDY; DRUG ACTIVITY; DRUG PURIFICATION; MOUSE; MYELOMA CELL; NONHUMAN; PH; PROCESS CONTROL; PROTEIN GLYCOSYLATION; STATISTICAL ANALYSIS; SYSTEM ANALYSIS; TEMPERATURE; VALIDATION PROCESS;

AMIDOHYDROLASES; ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY SPECIFICITY; CARBOHYDRATE SEQUENCE; CELL COUNT; CELL DIVISION; CELL SURVIVAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CULTURE TECHNIQUES; GLYCOSYLATION; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN G; ISOELECTRIC FOCUSING; MICE; MOLECULAR SEQUENCE DATA; MULTIPLE MYELOMA; OLIGOSACCHARIDES; PEPTIDE-N4-(N-ACETYL-BETA-GLUCOSAMINYL) ASPARAGINE AMIDASE; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; TEMPERATURE; TUMOR CELLS, CULTURED;

ANIMALIA; MURINAE;

EID: 0034609271     PISSN: 00063592     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0290(20000805)69:3<242::AID-BIT2>3.0.CO;2-I     Document Type: Article

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