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dc.contributor.authorGuttieres, Donovan
dc.contributor.authorSinskey, Anthony J
dc.contributor.authorSprings, Stacy L
dc.date.accessioned2021-05-03T22:04:31Z
dc.date.available2021-05-03T22:04:31Z
dc.date.issued2021-01
dc.date.submitted2021-03
dc.identifier.issn2516-4236
dc.identifier.urihttps://hdl.handle.net/1721.1/130550
dc.description.abstractBackground: Neutralizing antibodies (nAbs) against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) can play an important role in reducing impacts of the COVID-19 pandemic, complementing ongoing public health efforts such as diagnostics and vaccination. Rapidly designing, manufacturing and distributing nAbs requires significant planning across the product value chain and an understanding of the opportunities, challenges and risks throughout. Methods: A systems framework comprised of four critical components is presented to aid in developing effective end-to-end nAbs strategies in the context of a pandemic: (1) product design and optimization, (2) epidemiology, (3) demand and (4) supply. Quantitative models are used to estimate product demand using available epidemiological data, simulate biomanufacturing operations from typical bioprocess parameters and calculate antibody production costs to meet clinical needs under various realistic scenarios. Results:In a US-based case study during the 9-month period from March 15 to December 15, 2020, the projected number of SARS-CoV-2 infections was 15.73 million. The estimated product volume needed to meet therapeutic demand for the maximum number of clinically eligible patients ranged between 6.3 and 31.5 tons for 0.5 and 2.5 g dose sizes, respectively. The relative production scale and cost needed to meet demand are calculated for different centralized and distributed manufacturing scenarios. Conclusions: Meeting demand for anti-SARS-CoV-2 nAbs requires significant manufacturing capacity and planning for appropriate administration in clinical settings. MIT Center for Biomedical Innovation’s data-driven tools presented can help inform time-critical decisions by providing insight into important operational and policy considerations for making nAbs broadly accessible, while considering time and resource constraints.en_US
dc.publisherOxford University Press (OUP)en_US
dc.relation.isversionofhttp://dx.doi.org/10.1093/abt/tbab006en_US
dc.rightsCreative Commons Attribution NonCommercial License 4.0en_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/en_US
dc.sourceOxford University Pressen_US
dc.titleModels to inform neutralizing antibody therapy strategies during pandemics: the case of SARS-CoV-2en_US
dc.typeArticleen_US
dc.identifier.citationGuttieres, Donovan et al. "Models to inform neutralizing antibody therapy strategies during pandemics: the case of SARS-CoV-2." Antibody Therapeutics 4, 1 (January 2021): 60-71. © 2021 The Author(s)en_US
dc.contributor.departmentMassachusetts Institute of Technology. Department of Biologyen_US
dc.relation.journalAntibody Therapeuticsen_US
dc.eprint.versionFinal published versionen_US
dc.type.urihttp://purl.org/eprint/type/JournalArticleen_US
eprint.statushttp://purl.org/eprint/status/PeerRevieweden_US
dspace.date.submission2021-05-03T14:25:13Z
mit.journal.volume4en_US
mit.journal.issue1en_US
mit.licensePUBLISHER_CC
mit.metadata.statusComplete


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