Development of an end-to-end monoclonal antibody production process

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dc.contributor.advisorAllen, Evin
dc.contributor.advisorTangney, Mark
dc.contributor.authorPradeep, Rithwik
dc.date.accessioned2025-02-04T15:18:18Z
dc.date.available2025-02-04T15:18:18Z
dc.date.issued2024
dc.date.submitted2024
dc.description.abstractMonoclonal antibodies (mAbs) represent the dominant modality of biological therapeutics currently marketed. The manufacture of monoclonal antibodies consists of a series of processing steps including upstream cell culture, downstream purification and formulation and a final step of drug product manufacture. In this thesis, a small-scale end-to-end production process was developed for two monoclonal antibodies namely an anti-TNF Alpha mAb and cNISTmAb whose cell lines were sourced from commercial and public bodies respectively. A cell culture process for both cell lines was successfully developed including the creation of working cell banks (WCB). Titers were optimised, for both cell lines through a series of media, bioreactor and cell density modifications. In addition, the critical quality attributes of potency and purity were assessed via cell-based assays and SDS-PAGE respectively, that were designed and developed as part of this thesis. The potency of anti-TNF Alpha mAbs produced was assessed through two distinct in-vitro cell-based assays developed using HEK and L929 reporter cell lines and determined to be functional and more potent than a commercially available anti-TNF Alpha antibody The stability of cNISTmAb was also analysed across a range of temperature conditions from -20°C to 40°C after 50 days and also post-lyophilisation, with stability maintained at room temperature. Additional modifications of cNISTmAb were performed in an attempt to yield antibody fragments through pepsin digestion with partial success through pepsin digestion to yield F(ab’)2 fragments. This work demonstrates the successful production of two monoclonal antibodies and fragments but also sets the stage for further process improvement and enhanced characterisation to fully define and analyse an endto-end monoclonal antibody production systemen
dc.description.statusNot peer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationPradeep, R. 2024. Development of an end-to-end monoclonal antibody production process. MRes Thesis, University College Cork.
dc.identifier.endpage139
dc.identifier.urihttps://hdl.handle.net/10468/16959
dc.language.isoenen
dc.publisherUniversity College Corken
dc.rights© 2024, Rithwik Pradeep.
dc.rights.urihttps://creativecommons.org/publicdomain/zero/1.0/
dc.subjectCell culture
dc.subjectMonoclonal antibody
dc.subjectPurification
dc.titleDevelopment of an end-to-end monoclonal antibody production process
dc.typeMasters thesis (Research)en
dc.type.qualificationlevelMastersen
dc.type.qualificationnameMRes - Master of Researchen
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