Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies.
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ABSTRACT:
SUBMITTER: Japelj B
PROVIDER: S-EPMC5006049 | biostudies-literature | 2016 Aug
REPOSITORIES: biostudies-literature
Publications
Biosimilar structural comparability assessment by NMR: from small proteins to monoclonal antibodies.
Japelj Boštjan B Ilc Gregor G Marušič Jaka J Senčar Jure J Kuzman Drago D Plavec Janez J
Scientific reports 20160831
Biosimilar drug products must have a demonstrated similarity with respect to the reference product's molecules in order to ensure both the effectiveness of the drug and the patients' safety. In this paper the fusion framework of a highly sensitive NMR fingerprinting approach for conformational changes and mathematically-based biosimilarity metrics is introduced. The final goal is to translate the complex spectral information into biosimilarity scores, which are then used to estimate the degree o ...[more]
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