Establishment and Validation of an Automated System for the Antifactor IIa Assay: A Case Study of Potency Assessment of a Pharmaceutical Gel Formulation

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dc.authoridKaymak, Aysegul/0000-0001-5153-9602
dc.authoridARMAGAN, GULIZ/0000-0001-6466-2263
dc.contributor.authorOzgen, Gokselin
dc.contributor.authorTurk Gezer, Merve
dc.contributor.authorArmagan, Guliz
dc.contributor.authorKirmizibayrak, Petek Ballar
dc.contributor.authorYalcin, Ayfer
dc.contributor.authorOzer, Ozgen
dc.contributor.authorArslan, Banu Ozkirim
dc.date.accessioned2024-08-31T07:50:43Z
dc.date.available2024-08-31T07:50:43Z
dc.date.issued2024
dc.departmentEge Üniversitesien_US
dc.description.abstractAntithrombotic agents and anticoagulant drugs, such as those from the heparin family, are employed in clinical settings for the prevention and treatment of clotting, thromboembolism, and wound healing. The potency assessment of antithrombotic agents is typically conducted using antifactor IIa assay with manual systems which are time-consuming and often lack repeatability. Here, we present a novel automated system that significantly enhances assay repeatability, attaining an outstandingly low relative standard deviation (RSD) % of only 0.6% for repeatability. This system has been applied to a pharmaceutical gel formulation for wound healing developed by Abdi Ibrahim Pharmaceuticals R&D Center as a case study for validation. The automated system demonstrated substantial improvements over manual systems in linearity (R-2 = 0.9927), precision, accuracy, specificity, and robustness. The system aligns with the European Pharmacopoeia specifications, promising to enhance quality control across pharmaceutical formulations and conduct absorbance-based end-point assays within the pharmaceutical industry while offering increased throughput and cost-effectiveness.en_US
dc.description.sponsorshipAbdi Ibrahim Pharmaceuticals RD Centeren_US
dc.description.sponsorshipThis study was supported by the Abdi Ibrahim Pharmaceuticals R&D Center.en_US
dc.identifier.doi10.1021/acsomega.4c00290
dc.identifier.endpage18374en_US
dc.identifier.issn2470-1343
dc.identifier.issue16en_US
dc.identifier.pmid38680345en_US
dc.identifier.scopus2-s2.0-85190844969en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage18366en_US
dc.identifier.urihttps://doi.org/10.1021/acsomega.4c00290
dc.identifier.urihttps://hdl.handle.net/11454/105332
dc.identifier.volume9en_US
dc.identifier.wosWOS:001205185200001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAmer Chemical Socen_US
dc.relation.ispartofACS Omegaen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.snmz20240831_Uen_US
dc.subjectXaen_US
dc.titleEstablishment and Validation of an Automated System for the Antifactor IIa Assay: A Case Study of Potency Assessment of a Pharmaceutical Gel Formulationen_US
dc.typeArticleen_US

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