ATTENTION: The software behind KU ScholarWorks is being upgraded to a new version. Starting July 15th, users will not be able to log in to the system, add items, nor make any changes until the new version is in place at the end of July. Searching for articles and opening files will continue to work while the system is being updated.
If you have any questions, please contact Marianne Reed at mreed@ku.edu .
Formulation Studies to Develop Low-cost, Orally-delivered Secretory IgA Monoclonal Antibodies for Passive Immunization Against Enterotoxigenic Escherichia coli (Dataset)
dc.contributor.author | Bajoria, Sakshi | |
dc.contributor.author | Antunez, Lorena R. | |
dc.contributor.author | Kumru, Ozan S. | |
dc.contributor.author | Klempner, Mark | |
dc.contributor.author | Wang, Yang | |
dc.contributor.author | Cavacini, Lisa A. | |
dc.contributor.author | Joshi, Sangeeta B. | |
dc.contributor.author | Volkin, David B. | |
dc.date.accessioned | 2023-03-09T18:56:02Z | |
dc.date.available | 2023-03-09T18:56:02Z | |
dc.date.issued | 2023 | |
dc.identifier.uri | https://hdl.handle.net/1808/34032 | |
dc.description.abstract | Enterotoxigenic Escherichia coli (ETEC) is a common cause for diarrheal infections in children in low- and middle-income countries (LMICs). To date, no ETEC vaccine candidates have been approved. Passive immunization with low-cost, oral formulations of secretory IgA (sIgA) against ETEC is an alternative approach to protect high-risk populations in LMICs. Using a model sIgA monoclonal antibody (anti-LT sIgA2-mAb), the stability profiles of different formulations were assessed during storage and in in vitro digestion models (mimicking in vivo oral delivery). First, by employing various physicochemical techniques and an LT-antigen binding assay, three formulations with varying acid-neutralizing capacity (ANC) were evaluated to stabilize sIgA2-mAb during stress studies (freeze-thaw, agitation, elevated temperature) and during exposure to gastric phase digestion. Next, a low-volume, in vitro intestinal digestion model was developed to screen various additives to stabilize sIgA2-mAb in the intestinal phase. Finally, combination of high ANC buffers and decoy proteins were assessed to collectively protect sIgA2-mAb during in vitro sequential (stomach to intestine) digestion. Based on the results, we demonstrate the feasibility of low-cost, ‘single-vial’, liquid formulations of sIgA-mAbs delivered orally after infant feeding for passive immunization, and we suggest future work based on a combination of in vitro and in vivo stability considerations. | en_US |
dc.publisher | Elsevier | en_US |
dc.subject | Monoclonal antibodies | en_US |
dc.subject | Formulation | en_US |
dc.subject | Oral delivery | en_US |
dc.subject | Aggregation | en_US |
dc.subject | Stability | en_US |
dc.subject | Passive immunization | en_US |
dc.subject | Secretory IgA | en_US |
dc.title | Formulation Studies to Develop Low-cost, Orally-delivered Secretory IgA Monoclonal Antibodies for Passive Immunization Against Enterotoxigenic Escherichia coli (Dataset) | en_US |
dc.type | Dataset | en_US |
dc.identifier.doi | 10.17161/1808.34032 | en_US |
kusw.oaversion | Scholarly/refereed, publisher version | en_US |
kusw.oapolicy | This item does not meet KU Open Access policy criteria. | en_US |
dc.rights.accessrights | openAccess | en_US |