Antibody disulfide bond reduction during process development: Insights using a scale-down model process
نویسندگان
چکیده
منابع مشابه
Antibody disulfide bond reduction during process development: Insights using a scale-down model process
Background
متن کاملDevelopment and fine-tuning of a scale down model for process characterization studies of a monoclonal antibody upstream production process
Background It has always been an objective of process development and more recently it has also become a regulatory expectation to build robustness into and demonstrate proper control of a manufacturing process, thus ensuring that the biological product meets consistently its quality attributes and specifications. This is achieved mainly through systematic process development and understanding....
متن کاملEffects of antibody disulfide bond reduction on purification process performance and final drug substance stability
Antibody disulfide bond reduction during monoclonal antibody (mAb) production is a phenomenon that has been attributed to the reducing enzymes from CHO cells acting on the mAb during the harvest process. However, the impact of antibody reduction on the downstream purification process has not been studied. During the production of an IgG2 mAb, antibody reduction was observed in the harvested cel...
متن کاملMicrofabricated Modular Scale-Down Device for Regenerative Medicine Process Development
The capacity of milli and micro litre bioreactors to accelerate process development has been successfully demonstrated in traditional biotechnology. However, for regenerative medicine present smaller scale culture methods cannot cope with the wide range of processing variables that need to be evaluated. Existing microfabricated culture devices, which could test different culture variables with ...
متن کاملReduction and Reoxidation of a Critical Disulfide Bond in the Rabbit Antibody Molecule*
Treatment of 6.5-S rabbit antibody with pepsin removes a large inactive fragment. The residual portion of the molecule, which is still bivalent, has a molecular weight of 106,000 and a sedimentation coefficient of 4.6 to 5.0 S (1, 2). Reduction of a single, highly labile disulfide bond cleaves this fragment approximately in half (2, 3). The resulting 3.5-S fragments are univalent and inhibit sp...
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ژورنال
عنوان ژورنال: BMC Proceedings
سال: 2015
ISSN: 1753-6561
DOI: 10.1186/1753-6561-9-s9-p24