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Developers also describe financial barriers to advancing clinical and manufacturing progress.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/diphtheria-antitoxin-production-and-procurement-practices-and-challenges-online-report/458893/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/diphtheria-antitoxin-production-and-procurement-practices-and-challenges-online-report/458893.png","ImageObject",300,407,{"name":42,"@type":43},"SANS","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-22","2026-09-30",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",5,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"Why is equine diphtheria antitoxin (DAT) critical for treating respiratory diphtheria?","Question",{"text":63,"@type":64},"Prompt DAT administration neutralizes circulating toxin and can prevent irreversible toxin-related damage, reducing mortality.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What procurement and supply challenges did the study identify for DAT?",{"text":68,"@type":64},"Prices and availability vary, demand prediction is difficult, and global responders raise concerns about insufficient DAT supply during increasing outbreaks.",{"name":70,"@type":61,"acceptedAnswer":71},"How were data on DAT manufacturing, procurement, and monoclonal antibody development collected?",{"text":72,"@type":64},"The study used a literature and stakeholder mapping exercise, surveys of key procurement agencies and manufacturers, and key informant interviews with monoclonal antibody developers.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},458893,1791081189,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,100,105,109,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},"Comic",60,"comic",{"id":101,"doc_module":4,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},6,"Technology",50,"technology",{"id":106,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":107,"slug":108},7,40,"healthcare",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},8,"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":55,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":106,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":106,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":144,"preview_page_count":4},962090760505,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","ONLINE REPORT  \nDiphtheria Antitoxin Production and Procurement Practices and Challenges  \nCaroline Marshall, William Perea Caro,1 Ana Elena Chevez, Alejandro Costa, Lee Lee Ho, Peter J. Gardner, Christophe Guitton,1 Julien Potet, Erin Sparrow1  \nTreatment of respiratory diphtheria requires prompt administration of equine diphtheria antitoxin (DAT) to neutralize circulating toxin. We conducted surveys of key procurement agencies and manufacturers currently engaged in DAT manufacturing or procurement, along with key informant interviews with developers of monoclonal antibodies. Our findings indicate that prices and availability of DAT vary and that prediction of demand is challenging for both manufacturers and procurement agencies. Substantial concerns were raised over the inability to obtain enough DAT to respond to increasing global outbreaks. Monoclonal antibody developers noted financial challenges in advancing their clinical and manufacturing progress.  \nBeboore diadlyperiliaabltoe, xodiidp–contaihtherianinwgavascacineleaiansg cause of childhood deaths. After the introduction of the vaccine, the incidence of diphtheria declined. However, because of factors such as diminished routine vaccination coverage in some settings, outbreaks of diphtheria continue to occur; case-fatality rate (CFR) is ≈30% in nonvaccinated persons, with higher risk for death in young children \u003C5 years of age (1,2) . Cases have risen markedly since the early 2000s. In 2023, the World Health Organization (WHO) received reports of 24,782 cases from all regions, mostly in the African, Eastern Mediterranean, and South-East Asia regions; that total represented a dramatic increase from 10,027 reported cases in 2022 (3,4) . Diphtheria is believed to be underreported in many regions (5,6) .  \nAuthor affiliations: London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Public Health, London, UK (C. Marshall); World Health Organization, Geneva, Switzerland (C. Marshall, W. P. Caro, A. Costa, L. L. Ho, C. Guitton,  \nE. Sparrow); Wellcome Trust, London, UK (P.J. Gardner);  \nMédecins Sans Frontières, Paris, France (J. Potet) DOI [https://doi.org/10.3201/eid3112.250796](https://doi.org/10.3201/eid3112.250796)  \nCurrent treatment of respiratory diphtheria requires hospitalization, the administration of diphtheria antitoxin (DAT, sometimes referred to as eDAT, which contains polyclonal equine immunoglobulins), and antimicrobial drugs (typically penicillin, erythromycin, or another available macrolide) for a course of 14 days ( 7). The timely administration of DAT can prevent potentially irreversible toxin-related damage, reducing mortality rates by up to 76%(8) . DATis included in the WHO model Essential Medicines List; despite its importance, global availability of the product is perilously unreliable. Supply is limited; many producers have ceased production because of unpredictable demand, limited return on investment for continuing production, and the high regulatory requirements necessary to assure safety of bloodderived products. Most countries do not have DAT stockpiles and rely on donations or procurement by United Nations (UN) agencies. Response efforts tend to be agency specific, with no coordinating body or formal communication channels specific to the product. DAT availability is critical for case management and mitigation of diphtheria outbreaks; issues with DAT availability create challenges in preventing further spread of diphtheria (9,10) .  \nThe objectives of this study were to assess the current context and challenges for production and procurement of DAT from the perspectives of manufacturers and procurement agencies and to understand current development of candidate monoclonal antibodies for diphtheria and any challenges impeding their development toward licensure and broader production.  \nMethodology  \nWe conducted 3 key activities to collect the necessary data for this assessment. Activity 1 was a literature 1Retired.  \nEmerging ","cbCaik5b754A17W2","https://ap.wps.com/l/cbCaik5b754A17W2","pdf",809532,"English","# Background\n# Study Objectives\n# Methodology\n## Activity 1—Literature Review and Stakeholder Mapping\n## Activity 2—Surveys of Procurement Agencies and Manufacturers\n## Activity 3—Key Informant Interviews","[{\"question\":\"Why is equine diphtheria antitoxin (DAT) critical for treating respiratory diphtheria?\",\"answer\":\"Prompt DAT administration neutralizes circulating toxin and can prevent irreversible toxin-related damage, reducing mortality.\"},{\"question\":\"What procurement and supply challenges did the study identify for DAT?\",\"answer\":\"Prices and availability vary, demand prediction is difficult, and global responders raise concerns about insufficient DAT supply during increasing outbreaks.\"},{\"question\":\"How were data on DAT manufacturing, procurement, and monoclonal antibody development collected?\",\"answer\":\"The study used a literature and stakeholder mapping exercise, surveys of key procurement agencies and manufacturers, and key informant interviews with monoclonal antibody developers.\"}]","Diphtheria Antitoxin Production and Procurement Practices and Challenges - Online Report | PDF",1790754705,18]