COMPOSITIONS COMPRISING FUSION PROTEIN AND ANALYTICAL ATTRIBUTES THEREOF

The present invention discloses a therapeutic composition comprising fusion protein with reduced heterogeneity in the glycosylation profile of the protein and methods thereof. More particularly the invention provides the composition with reduced heterogeneity in the glycosylation profile. By reducin...

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Bibliographische Detailangaben
Hauptverfasser: AAMUDALAPALLI, Haribabu, SAIDARAO, Korampalli, RAGHUPROLU, Sharath Chandra, MANDAL, Samir Kumar, HALDAR, Suranjana, PANDURANGAN, Pandiaraja
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:The present invention discloses a therapeutic composition comprising fusion protein with reduced heterogeneity in the glycosylation profile of the protein and methods thereof. More particularly the invention provides the composition with reduced heterogeneity in the glycosylation profile. By reducing heterogeneity, the resultant preparation is expected to exhibit superior, consistent results in terms of safety, purity and potency. The invention is of particular importance as it can form the part of the critical quality attributes (CQA) that help in ensuring batch-to-batch consistency and predicted shelf-life of complex protein molecules.