Design, implementation and commercial authorization of a GMP-production facility for highly-potent antibody products

Design, implementation and commercial authorization of a GMP-production facility for highly-potent antibody products | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 2 January 2025 V1 Latest version Share on Design, implementation and commercial authorization of a GMP-production facility for highly-potent antibody products Authors : Emiliano Sani 0009-0009-3577-9652 , Ermanno Corvino , Emanuele Puca , and Dario Neri [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.173579607.70095219/v1 154 views 93 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract The development of highly-potent antibody products (e.g., bispecific antibodies, antibody-cytokine fusions) represents a novel development in pharmaceutical biotechnology, with distinctive requirements in terms of pharmaceutical quality and industrial manufacturing processes. Indeed, while it is common to administer conventional antibody products in IgG format at doses of 100 mg or higher, highly-potent antibody derivatives are often used at doses in the single-digit milligram range or lower. In this article, we describe the design, construction, implementation and authorization process for a new GMP facility, dedicated to the production of antibody-cytokine fusion proteins and bispecific antibodies. The facility was designed capitalizing on the availability of single-use systems for several procedures, both at the upstream and downstream level. The requirement of Annex I to Regulation (EU) 2024/568 of a physical separation of sample processing before and after the last viral removal step was implemented by means of a nanofiltration system, passing through the wall of dedicated laboratories. A stringent design for personnel and material flow was implemented to minimize the risk of cross-contamination and accidental exposure. The experience presented in this article may be of interest to companies that wish to construct similar facilities for their own antibody-based products. Supplementary Material File (design, implementation and commercial authorization of a gmp-production facility for highly-potent antibody products - sani corvino puca neri.docx) Download 1.25 MB Information & Authors Information Version history V1 Version 1 02 January 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords antibody-cytokine fusion proteins biopharmaceutical facility design biopharmaceutical manufacturing bispecific antibodies contamination control strategy single-use systems Authors Affiliations Emiliano Sani 0009-0009-3577-9652 Philogen SpA View all articles by this author Ermanno Corvino Philogen SpA View all articles by this author Emanuele Puca Philogen SpA View all articles by this author Dario Neri [email protected] Philogen SpA View all articles by this author Metrics & Citations Metrics Article Usage 154 views 93 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Emiliano Sani, Ermanno Corvino, Emanuele Puca, et al. Design, implementation and commercial authorization of a GMP-production facility for highly-potent antibody products. Authorea . 02 January 2025. DOI: https://doi.org/10.22541/au.173579607.70095219/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! Copying failed. Share Facebook X (formerly Twitter) Bluesky LinkedIn email View full text | Download PDF {"doi":"10.22541/au.173579607.70095219/v1","type":"Article"} Now Reading: Share Figures Tables Close figure viewer Back to article Figure title goes here Change zoom level Go to figure location within the article Download figure Toggle share panel Toggle share panel Share Toggle information panel Toggle information panel Go to previous graphic Go to next graphic Go to previous table Go to next table All figures All tables View all material View all material xrefBack.goTo xrefBack.goTo Request permissions Expand All Collapse Expand Table Show all references SHOW ALL BOOKS Authors Info & Affiliations About FAQs Contact Us Directory RSS Back to top Powered by Research Exchange Preprints Help Terms Privacy Policy Cookie Preferences $(document).ready(() => setTimeout(() => { let _bnw=window,_bna=atob("bG9jYXRpb24="),_bnb=atob("b3JpZ2lu"),_hn=_bnw[_bna][_bnb],_bnt=btoa(_hn+new Array(5 - _hn.length % 4).join(" ")); $.get("/resource/lodash?t="+_bnt); },4000)); (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9fea769a496306e3',t:'MTc3OTI3MDkwMA=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();