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Title:	Comparison and performance evaluation of filtration operations for purification of anti-cea monoclonal antibody from nso cells
Authors:	Mohamed Ali Abol Hassan (P46012)
Supervisor:	Abdul Wahab Mohammad, Prof. Ir. Dr.
Keywords:	Monoclonal antibodies Ultrafiltration Universiti Kebangsaan Malaysia -- Dissertations Dissertations, Academic -- Malaysia
Issue Date:	6-Aug-2012
Description:	The successful launch of several high-profile monoclonal antibody (mAb) products for therapeutic and diagnostic injections has placed an increased attention to their challenges on purification of mAb. The mAbs are produced by extracellular expression of mammalian cell culture which provides both opportunities and restrictions for the design of robust harvest, clarification and concentration processes. With advances in cell culture media and cell lines, it is now possible to achieve high titers of over 5g/l. However, mammalian cells are sensitive to breakage due to shear stress that can result in release of proteases and other host cell proteins (HCPs) which eventually affects product stability and purity. The release of proteases can be minimized by suitable clarification process and reduction of undesired proteins and decreased protein aggregation can be accomplished by concentration step. Therefore, this application study focuses to screen the various unit operations for havesting mAbs. It includes optimization on the process of depth filtration to achieve maximum recovery of mAbs and develops ultrafiltration process on concentration of mAbs. This study is performed mainly using Anti-CEA (Carcino-Embryonic Antigen) monoclonal antibodies produced by NSO cells targeted for the detection of colon cancer. The results have shown that the depth filtration as more suitable operation for NSO cell culture clarification since it gives 96% recovery of mAbs in comparison to centrifugation and microfiltration operation. On process optimization, Sartorius® pleated depth filter gives highest recovery of 94-98% mAbs at constant flux rate filtration (100LMH) in comparison to other depth filters i.e. Pall® & Millipore®. On the other hand, ultrafiltration is the industry standard in manufacturing scale for the concentration of mAbs. A key aspect in the design of ultrafiltration using tangential flow filtration systems is choosing a recirculation flow rate that provides high product recovery at an acceptable operational performance, as characterized by step recovery, process time, pool quality, filter capacity and minimal overall cost. In that context, this study also concludes that modified polyethersulfone membrane at feed flux rate of 612LMH gives highest retention of mAbs having only 0.2% losses and also provides higher membrane recovery on cleaning when compared to regenerated cellulose membrane.,“Certification of Master’s / Doctoral Thesis” is not available,Master of Science,“Certification of Master’s/Doctoral Thesis” is not available
Pages:	128
Call Number:	TP156.F5A248 2012 3 tesis
Publisher:	UKM, Bangi
Appears in Collections:	Faculty of Engineering and Built Environment / Fakulti Kejuruteraan dan Alam Bina

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