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Master Thesis

Développement d’une plateforme de production d’anticorps monoclonaux

Abstract : With the decreasing number of traditional molecule sales, the biotechnology sector has become one of the major biopharmaceutical field. Among these molecules, monoclonal antibodies are promising for modern medicine due to their use within a variety of therapies, including those against several forms of cancer, multiple sclerosis and viral infections. Monoclonal antibodies are extremely efficient as they allow a highly specific, complex set of functions that cannot be mimicked by simple chemical compounds. Nowadays, among the ten best-selling drugs in the world, five are produced by biological means, three of them being monoclonal antibodies. Significant capital investments are required for development but the return on investment is high: the sale price of monoclonal antibodies averaged 8,000 dollars per gram in 2009. Pharmaceuticals companies have so far succeeded in facing the multiple challenges regarding public health on one hand and financial aspect on the other hand. Scientific breakthroughs have resulted in the design of more and more effective molecules at lower cost. A promising future awaits the monoclonal antibody market. The commercial success of those drugs has led to a need for very large-scale production platforms. These platforms include all stages necessary for the production, allowing to maintain desired quality attributes and cost effectiveness while reducing the delivery time to market and providing manufacturing flexibility. This work is dealing with the development of an efficient production platform which begins with the selection and generation of the host cell line. Mammalian and CHO cell lines are the host of choice for antibody production. They allow meeting regulatory requirements in order to safely administer treatments. Optimization of media and bioreactor culture conditions is necessary to achieve the required productivity and reduce recombinant protein production cost. These processes are then transferred towards high scale platforms. Large scale production of the therapeutic molecule while maintaining productivity and product quality is challenging for pharmaceutical companies. Modern cell culture processes can achieve high antibody concentrations. However it is generally observed that production capacities can be a limiting factor for the increasing demand of monoclonal antibodies. For the past ten years, biopharmaceutical companies have been exploring innovative solutions such as the optimization of current cell culture processes or the development of new technologies. These solutions are also presented in this work.
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Master Thesis
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Submitted on : Monday, January 19, 2015 - 2:56:55 PM
Last modification on : Wednesday, August 23, 2017 - 4:31:00 PM
Long-term archiving on: : Monday, April 20, 2015 - 10:50:25 AM

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  • HAL Id : dumas-01104942, version 1

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François Laborde. Développement d’une plateforme de production d’anticorps monoclonaux. Sciences pharmaceutiques. 2014. ⟨dumas-01104942⟩

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