Protein A chromatography in monoclonal antibody purification

dc.contributor.authorCurtis, Michael
dc.date.accessioned2018-11-14T19:08:21Z
dc.date.available2018-11-14T19:08:21Z
dc.date.graduationmonthDecember
dc.date.issued2018-12-01
dc.description.abstractThe bio-pharmaceutical industry began over 30 years ago with the production of human insulin and has shown incredible growth ever since. With forecasted annual worldwide sales of over $450B in 2025 for biopharmaceuticals, they are expected to be at least 25% of the entire pharmaceutical market. Therapeutics based on monoclonal antibodies (mAbs) make up roughly a third of all biopharmaceutical sales with indications from asthma, to cancer, to Parkinson’s disease. The recent approval of the first biosimilar mAb products in the US and Europe has exposed up to 20 of the top grossing biologic products to competition for the first time, while 75% of the US market is expected to lose patent exclusivity by 2020. With the increased competition from biosimilars, the costs associated with producing mAb based therapeutics will be a constraint on maintaining market share going forward. The majority of the total manufacturing costs for mAbs resides in the downstream processing where Protein A chromatography is the predominantly employed technology for the primary capture step. With Protein A’s high unit cost of up to $15,000 per liter and susceptibility to deamidification when exposed to high pH cleaning and sanitization chemicals, it is no surprise that many mAb manufacturers are considering alternatives. The objective of this work is to review the production process of mAb therapeutics, with a specific focus on the advantages, disadvantages, and alternatives to Protein A affinity chromatography as the primary capture step in downstream processing.
dc.description.advisorJames H. Edgar
dc.description.degreeMaster of Science
dc.description.departmentDepartment of Chemical Engineering
dc.description.levelMasters
dc.identifier.urihttp://hdl.handle.net/2097/39284
dc.language.isoen_US
dc.publisherKansas State University
dc.rights© the author. This Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s).
dc.rights.urihttp://rightsstatements.org/vocab/InC/1.0/
dc.subjectmAb
dc.subjectProtein A
dc.subjectChromatography
dc.subjectantibody
dc.titleProtein A chromatography in monoclonal antibody purification
dc.typeReport

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