Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies

Drug Development Research

Volumn 61, Issue 3, 2004, Pages 137-154

  Harris, Reed J ^a,c   Shire, Reven J ^b   Winter, Charles ^c  

^a Analytical Chemistry Department   (United States)

^b Process Research and Development   (United States)

^c GENENTECH INC   (United States)

Author keywords

Analytical characterization; Formulation; Monoclonal antibody; Ultrafiltration

Indexed keywords

ABCIXIMAB; ADALIMUMAB; ALEMTUZUMAB; BASILIXIMAB; CHIMERIC ANTIBODY; DACLIZUMAB; GEMTUZUMAB OZOGAMICIN; HUMAN MONOCLONAL ANTIBODY; IBRITUMOMAB TIUXETAN; IMMUNOGLOBULIN G; INFLIXIMAB; INSULIN; MONOCLONAL ANTIBODY; OKT 3; PALIVIZUMAB; RITUXIMAB; TRASTUZUMAB;

ANALYTIC METHOD; BIOTECHNOLOGY; BREAST CANCER; CANCER IMMUNOTHERAPY; CAPILLARY ELECTROPHORESIS; CHRONIC LYMPHATIC LEUKEMIA; CORONARY ARTERY DISEASE; CROHN DISEASE; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG MANUFACTURE; DRUG POTENCY; DRUG SAFETY; DRUG STABILITY; DRUG STORAGE; ELECTROSPRAY MASS SPECTROMETRY; FOOD AND DRUG ADMINISTRATION; FREEZE DRYING; GEL PERMEATION CHROMATOGRAPHY; GRAFT REJECTION; HUMAN; IMMUNOPROPHYLAXIS; IMMUNOTHERAPY; LEUKEMIA; LIQUID; NONHODGKIN LYMPHOMA; ORGAN TRANSPLANTATION; PERCUTANEOUS CORONARY INTERVENTION; POLYACRYLAMIDE GEL ELECTROPHORESIS; POWDER; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; REVIEW; RHEUMATOID ARTHRITIS; ULTRAFILTRATION; VIRUS INFECTION;

EID: 3843058933     PISSN: 02724391     EISSN: None     Source Type: Journal    
DOI: 10.1002/ddr.10344     Document Type: Review

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