Developing an upstream process for a monoclonal antibody including medium optimization
نویسندگان
چکیده
منابع مشابه
Developing an upstream process for a monoclonal antibody including medium optimization
Background Monoclonal antibodies have been established as important therapeutics in cancer and autoimmune diseases. Hence, there is a growing interest in the production of monoclonal antibodies in pharmaceutical industry. In order to reduce timelines and costs of production the process and medium development is of central importance. Perfusion processes are well known to achieve higher producti...
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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....
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Background Mammalian cells are used extensively in the production of recombinant proteins, and of monoclonal antibodies (MAbs) in particular. The trend towards avoiding animal-derived components in biopharmaceutical production processes has led to the extensive use of nonanimal origin hydrolysates such as plant hydrolysates or yeast hydrolysates. The source of hydrolysates affects cell growth a...
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capture ELISA system was developed for diagnosis of visceral leishmaniasis (VL) using a monoclonal antibody raised against an antigen previously detected in the urine of VL patients. Urine samples from confirmed VL cases from Yemen, Nepal, Spain, Sudan and Brazil were tested in the capture ELISA in comparison with urine samples from endemic and non-endemic areas along with urine samples from pa...
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A steady increase of product titers and the corresponding change in impurity composition represent a challenge for development and optimization of antibody production processes. Additionally, increasing demands on product quality result in higher complexity of processes and analytics, thereby increasing the costs for product work-up. Concentration and composition of impurities are critical for ...
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ژورنال
عنوان ژورنال: BMC Proceedings
سال: 2013
ISSN: 1753-6561
DOI: 10.1186/1753-6561-7-s6-p34