Single use bioreactors for the clinical production of monoclonal antibodies – a study to analyze the performance of a CHO cell line and the quality of the produced monoclonal antibody

作者: Sonja Diekmann , Constanze Dürr , Alexander Herrmann , Ingo Lindner , Daniela Jozic

DOI: 10.1186/1753-6561-5-S8-P103

关键词: Pore sizeSpargingUnit operationProcess engineeringBioreactorSingle-use bioreactorOxygen transfer coefficientMaterials sciencePhysical designSingle use

摘要: Background In recent years, the use of disposables in pharmaceutical industry has increased extensively. Disposables can be used many areas biopharmaceutical production. The not only reduces investment costs, but also requires less manpower to operate, since time consuming change-over procedures are significantly reduced. addition, enable a high flexibility by reducing unit operation times such as cleaning and sterilization well validation these [1]. Disposable bioreactors subdivided into two main groups, static dynamic systems. systems differ with regard power input stirred, vibromixed or wave-induced [2]. Since input, mixing time, tip speed oxygen transfer coefficient may influence cell culture process product quality itself, thorough characterization system is necessary [3]. SSB (stainless steel bioreactors) SUB (single terms their physical design. Usually, an equipped three stirrer blades. contrast, stirred SUBs usually have just one blade. design position significantly. These distinctions lead different characteristics regarding speed. characterized lower higher time. order maintain sufficient coefficient, single bioreactor micro sparger pore size 25 μm. Furthermore, pure achieve dissolved concentrations cultivation medium. This study describes technical differences on performance CHO line monoclonal antibody.

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