Consistent manufacturing and quality control of a highly complex recombinant polyclonal antibody product for human therapeutic use

Biotechnology and Bioengineering

Volumn 108, Issue 9, 2011, Pages 2171-2181

  Frandsen, Torben P ^a   Næsted, Henrik ^a   Rasmussen, Søren K ^a   Hauptig, Peter ^b   Wiberg, Finn C ^a,d   Rasmussen, Lone Kjær ^a   Jensen, Anne Marie Valentin ^a,d   Persson, Pia ^b   Wikén, Margareta ^b   Engström, Anders ^b   Jiang, Yun ^b   Thorpe, Susan J ^c   Förberg, Cecilia ^b   Tolstrup, Anne B ^a  

^a Symphogen AS   (Denmark)

^b BIOVITRUM AB   (Sweden)

^c NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^d NOVO NORDISK A S   (Denmark)

Author keywords

Cell banking strategy; Characterization strategy; Manufacturing consistency; Recombinant polyclonal antibody

Indexed keywords

ANALYTICAL METHOD; ANTIBODY THERAPY; BENEFICIAL EFFECTS; BIOLOGICAL EFFECTS; CELL BANKING; COMPLEX ENTITIES; COST-EFFICIENT; FUNCTIONAL LEVELS; HUMAN DISEASE; HUMAN THERAPEUTICS; INFECTIOUS AGENTS; MANUFACTURING CONCEPTS; MANUFACTURING PROCESS; POLYCLONAL ANTIBODY; QUALITY ATTRIBUTES; THERAPEUTIC EFFICACY;

CHEMICAL ANALYSIS; DISEASE CONTROL; DISEASES; QUALITY CONTROL;

ANTIBODIES;

RECOMBINANT ANTIBODY; RECOMBINANT POLYCLONAL ANTIBODY; ROZROLIMUPAB; UNCLASSIFIED DRUG;

ANIMAL CELL; ARTICLE; CHEMISTRY; CONTROLLED STUDY; DRUG CONTROL; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG RELEASE; DRUG USE; FEMALE; GENETIC ANALYSIS; IMMUNOTHERAPY; NONHUMAN; PROTEIN ANALYSIS; QUALITY CONTROL;

BIOTECHNOLOGY; CELL LINE; HUMANS; IMMUNOGLOBULIN G; QUALITY CONTROL; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS;

EID: 79960471593     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.23166     Document Type: Article

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