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dc.contributor.authorSchieferstein, Jeremy M.
dc.contributor.authorReichert, Paul
dc.contributor.authorNarasimhan, Chakravarthy N.
dc.contributor.authorYang, Xiaoyu
dc.contributor.authorDoyle, Patrick S.
dc.date.accessioned2022-02-16T16:48:05Z
dc.date.available2022-02-16T16:48:05Z
dc.date.issued2021-01-20
dc.identifier.issn2366-3987
dc.identifier.issn2366-3987
dc.identifier.urihttps://hdl.handle.net/1721.1/140411
dc.description.abstractMonoclonal antibodies are therapeutic molecules known for their high specificity and versatility in the treatment of cancer and autoimmune disorders, but dosage forms are typically limited to low concentrations and large fluid volumes due to formulation challenges. Hydrogel microsphere formulations offer a route to quicker, patient-friendly dosing regimens for monoclonal antibodies with high loading and favorable flow properties needed for injection through a narrow syringe needle under moderate applied force. Crystals of an intact monoclonal antibody are prepared as a concentrated suspension (>300 mg mL−1) which is then encapsulated within hydrogel microspheres with diameters as small as 30 µm. The hydrogel microspheres contain up to 56 wt% (dry basis) monoclonal antibody and release within 4 days under in vitro dissolution conditions. The hydrogel microspheres are concentrated into densely packed suspensions containing up to 300 mg mL−1 monoclonal antibody to evaluate their flow. These hydrogel formulations shear-thin and have lower viscosity when compared to both liquid and suspended crystal forms of the monoclonal antibody, demonstrating the potential of hydrogel microsphere encapsulants as a carrier which can mask undesirable flow properties of concentrated antibody therapeutics.en_US
dc.languageen
dc.publisherWileyen_US
dc.relation.isversionofhttp://dx.doi.org/10.1002/adtp.202000216en_US
dc.rightsCreative Commons Attribution-Noncommercial-Share Alikeen_US
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/en_US
dc.sourceWileyen_US
dc.titleHydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulationsen_US
dc.typeArticleen_US
dc.identifier.citationSchieferstein, J.M., Reichert, P., Narasimhan, C.N., Yang, X. and Doyle, P.S. (2021), Hydrogel Microsphere Encapsulation Enhances the Flow Properties of Monoclonal Antibody Crystal Formulations. Adv. Therap., 4: 2000216.en_US
dc.contributor.departmentMassachusetts Institute of Technology. Department of Chemical Engineering
dc.relation.journalAdvanced Therapeuticsen_US
dc.eprint.versionAuthor's final manuscripten_US
dc.type.urihttp://purl.org/eprint/type/JournalArticleen_US
eprint.statushttp://purl.org/eprint/status/PeerRevieweden_US
dspace.date.submission2022-02-09T20:06:13Z
mit.journal.volume4en_US
mit.journal.issue4en_US
mit.licenseOPEN_ACCESS_POLICY
mit.metadata.statusAuthority Work Neededen_US


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