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dc.contributor.authorCosta, A. R.-
dc.contributor.authorWithers, Joanne-
dc.contributor.authorRodrigues, E.-
dc.contributor.authorMcLoughlin, Niaobh-
dc.contributor.authorHenriques, Mariana-
dc.contributor.authorOliveira, Rosário-
dc.contributor.authorRudd, Pauline M.-
dc.contributor.authorAzeredo, Joana-
dc.description.abstractN-glycosylation is one of the most critical parameters affecting the biological activity of therapeutic monoclonal antibodies (mAbs), and should therefore be closely monitored and controlled to guarantee a consistent and high-quality product in biopharmaceutical processes. In the present work, the effect of the time-consuming step of gradual cell adaptation to serum-free conditions on the glycosylation profile of a mAb produced by CHO-K1 cells was evaluated. High-performance liquid chromatography analysis revealed important changes in mAb glycosylation patterns in all steps of serum reduction. These changes could be grouped in two distinct phases of the process of adaptation: middle (2.5 to 0.15% serum) and final (0.075 and 0% serum). For intermediate levels of serum, a desirable increase of galactosylation and decrease of fucosylation, but an undesirable increase in sialylation were observed; while the inverse was obtained at the final stages of adaptation. These divergences may be related to the reduction of serum supplementation, to variations in the levels of cell density and viability achieved at these stages, and to the natural shift of the cell growth mode during adaptation from adherent to suspended. The divergent glycan profiles obtained in this study demonstrate a strong influence of the adaptation process on mAb glycosylation, suggesting that control and monitoring of product quality should be implemented at the early stages of process development.por
dc.description.sponsorshipThe authors acknowledge funding and support from the Portuguese Foundation for Science and Technology (FCT), namely grant reference SFRH/BD/46660/2008 for Ana Rita Costa and SFRH/BD/46661/2008 for Maria Elisa Rodrigues. Also, a special acknowledgement to Biotecnol S.A. (Lisbon, Portugal) for providing the monoclonal antibody used in this study.por
dc.subjectMonoclonal antibodypor
dc.subjectChinese hamsterpor
dc.titleThe impact of cell adaptation to serum-free conditions on the glycosylation profile of a monoclonal antibody produced by CHO cellspor
degois.publication.titleNew Biotechnologypor
dc.publisher.uriElsevier BVpor
dc.subject.wosScience & Technologypor
sdum.journalNew Biotechnologypor
Appears in Collections:CEB - Publicações em Revistas/Séries Internacionais / Publications in International Journals/Series

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