Monoclonal antibody disulfide reduction during manufacturing
نویسندگان
چکیده
منابع مشابه
Disulphide bond reduction of a therapeutic monoclonal antibody during cell culture manufacturing operations
Background Disulphide bonding is critical to maintaining immunoglobulin (IgG) tertiary and quaternary structure for therapeutic monoclonal antibodies (MAb). Both interand intra-chain disulphide bonds are formed intracellularly in the expression host prior to secretion and purification during MAb production processes. Disulphide bond shuffling has previously been reported for IgG2[1,2] and disul...
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Monoclonal antibodies have proved to be a highly successful class of therapeutic products. Large-scale manufacturing of pharmaceutical antibodies is a complex activity that requires considerable effort in both process and analytical development. If a therapeutic protein cannot be stabilized adequately, it will lose partially or totally its therapeutic properties or even cause immunogenic reacti...
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Background
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UNLABELLED Spray-dried monoclonal antibody (mAb) powders may offer applications more versatile than the freeze-dried cake, including preparing high-concentration formulations for subcutaneous administration. Published studies on this topic, however, are generally scarce. This study evaluates a pilot-scale spray dryer against a laboratory-scale dryer to spray-dry multiple mAbs in consideration o...
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ژورنال
عنوان ژورنال: mAbs
سال: 2013
ISSN: 1942-0862,1942-0870
DOI: 10.4161/mabs.24725