A simulation study on downstream processing of monoclonal antibodies production using superpro designer

The production of monoclonal antibodies and Fc fusion proteins form the largest and most rapidly expanding category of the biopharmaceuticals today with the annual sales exceeding USD$8 billion with the application across a wide range of diseases especially for the immunotherapy purpose. With the gr...

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Main Author: Muhamad Nur Iman, Ahmad Razali
Format: Undergraduates Project Papers
Language:English
Published: 2009
Subjects:
Online Access:http://umpir.ump.edu.my/id/eprint/1078/1/41.A%20simulation%20study%20on%20downstream%20processing%20of%20monoclonal%20antibodies%20production%20using%20superpro%20designer.pdf
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author Muhamad Nur Iman, Ahmad Razali
author_facet Muhamad Nur Iman, Ahmad Razali
author_sort Muhamad Nur Iman, Ahmad Razali
collection UMP
description The production of monoclonal antibodies and Fc fusion proteins form the largest and most rapidly expanding category of the biopharmaceuticals today with the annual sales exceeding USD$8 billion with the application across a wide range of diseases especially for the immunotherapy purpose. With the growth of this class of biomolecules, significant thought on the most efficient downstream processing steps for monoclonal antibodies has been taken into the highly consideration by the manufacturer in order to obtain the highest yield with the highest purity of the product which is why the simulation study are crucial in this development. The objectives of this study are to propose the most suitable framework of downstream processing for monoclonal antibodies production in order to achieve highest purities of mAbs and to stimulate the propose framework using SuperPro Designer® simulator. The process was initially done via the disk stack centrifuge and followed by microfiltration in order to harvest the protein. Three column of chromatography (Protein A affinity, anion exchange and hydrophobic interaction) were used to obtain the highest purity of the therapeutic. Viral inactivation also was employed to free the product from the endotoxins and pyrogens. The propose steps then, was introduced into the SuperPro Designer® simulator and the result obtained were 100% purity of IgG with 9.49345 g/L of concentration and 0.16687 kg/batch with 76.3% of recovery of the product.
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spelling UMPir10782023-02-23T07:58:55Z http://umpir.ump.edu.my/id/eprint/1078/ A simulation study on downstream processing of monoclonal antibodies production using superpro designer Muhamad Nur Iman, Ahmad Razali QR180 Immunology The production of monoclonal antibodies and Fc fusion proteins form the largest and most rapidly expanding category of the biopharmaceuticals today with the annual sales exceeding USD$8 billion with the application across a wide range of diseases especially for the immunotherapy purpose. With the growth of this class of biomolecules, significant thought on the most efficient downstream processing steps for monoclonal antibodies has been taken into the highly consideration by the manufacturer in order to obtain the highest yield with the highest purity of the product which is why the simulation study are crucial in this development. The objectives of this study are to propose the most suitable framework of downstream processing for monoclonal antibodies production in order to achieve highest purities of mAbs and to stimulate the propose framework using SuperPro Designer® simulator. The process was initially done via the disk stack centrifuge and followed by microfiltration in order to harvest the protein. Three column of chromatography (Protein A affinity, anion exchange and hydrophobic interaction) were used to obtain the highest purity of the therapeutic. Viral inactivation also was employed to free the product from the endotoxins and pyrogens. The propose steps then, was introduced into the SuperPro Designer® simulator and the result obtained were 100% purity of IgG with 9.49345 g/L of concentration and 0.16687 kg/batch with 76.3% of recovery of the product. 2009-04 Undergraduates Project Papers NonPeerReviewed pdf en http://umpir.ump.edu.my/id/eprint/1078/1/41.A%20simulation%20study%20on%20downstream%20processing%20of%20monoclonal%20antibodies%20production%20using%20superpro%20designer.pdf Muhamad Nur Iman, Ahmad Razali (2009) A simulation study on downstream processing of monoclonal antibodies production using superpro designer. Faculty of Chemical & Natural Resources Engineering, Universiti Malaysia Pahang.
spellingShingle QR180 Immunology
Muhamad Nur Iman, Ahmad Razali
A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title_full A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title_fullStr A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title_full_unstemmed A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title_short A simulation study on downstream processing of monoclonal antibodies production using superpro designer
title_sort simulation study on downstream processing of monoclonal antibodies production using superpro designer
topic QR180 Immunology
url http://umpir.ump.edu.my/id/eprint/1078/1/41.A%20simulation%20study%20on%20downstream%20processing%20of%20monoclonal%20antibodies%20production%20using%20superpro%20designer.pdf
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