Manufacturing of biodrugs: Need for harmonization in regulatory standards

BioDrugs

Volumn 23, Issue 4, 2009, Pages 217-229

  Sahoo, Niharika ^a   Choudhury, Koel ^a   Manchikanti, Padmavati ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY   (India)

Author keywords

[No Author keywords available]

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ALTEPLASE; BETA1A INTERFERON; BEVAC; BIOVAC B; CERITON; DACLIZUMAB; EFALIZUMAB; ELOVAC B; EMGRAST; EPOFER; EPOFIT; ERYKINE; ERYPRO; ERYTHROPOIETIN; EVINAC HB; GENE VAC B; GRAFEEL; GRANULOCYTE COLONY STIMULATING FACTOR; HEPATITIS B VACCINE; HUMAN GROWTH HORMONE; INDIKINASE; INFLIXIMAB; INSUGEN; INSULIN; INTERFERON BETA SERINE; INTERLEUKIN 2; MACROGEN; MARKFERON; METHIONYL RECOMBINANT HUMAN GROWTH HORMONE; MONOCLONAL ANTIBODY; NEUKINE; NUGRAF; PROTEIN; RECIL; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT DNA HEPATITIS B VACCINE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GROWTH HORMONE; RECOMBINANT HEPATITIS B VACCINE; RECOMBINANT HUMAN EPIDERMAL GROWTH FACTOR; RECOMBINANT STREPTOKINASE; REDITUX; REGEN D; REVAC B; SHANFERON; SHANPOIETIN; SHANVAC; STPASE; STREPTOKINASE; THROMBOPOIETIN; UNCLASSIFIED DRUG; WEPOX; XPHIL;

ANALYSIS; CELL MATURATION; CLINICAL ARTICLE; COMPARATIVE STUDY; DOWNSTREAM PROCESSING; DRUG DECOMPOSITION; DRUG FORMULATION; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; GROWTH HORMONE DEFICIENCY; HEPATITIS C; HOST CELL; HUMAN; KIDNEY ANEMIA; KIDNEY DISEASE; MULTIPLE SCLEROSIS; NONHUMAN; PRIORITY JOURNAL; PROTEIN MODIFICATION; PURE RED CELL ANEMIA; REVIEW; STANDARD; THROMBOCYTOPENIA;

ANIMALS; BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; DRUG APPROVAL; HUMANS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 69249232178     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11317110-000000000-00000     Document Type: Review

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