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

Autor:	Ozgen G; Abdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye., Turk Gezer M; Abdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye., Armagan G; Faculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye., Ballar Kirmizibayrak P; Faculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye., Yalcin A; Faculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye., Ozer O; Faculty of Pharmacy, Department of Pharmaceutical Technology, Ege University, Bornova, Izmir 35040, Türkiye., Ozkirim Arslan B; Abdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye., Kayar G; Abdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye., Dude UK; Abdi İbrahim Pharmaceuticals Research & Development Center (R&D), Istanbul 34538, Türkiye., Kaymak Ozdemir A; Faculty of Pharmacy, Department of Biochemistry, Ege University, Bornova, Izmir 35040, Türkiye.
Jazyk:	angličtina
Zdroj:	ACS omega [ACS Omega] 2024 Apr 13; Vol. 9 (16), pp. 18366-18374. Date of Electronic Publication: 2024 Apr 13 (Print Publication: 2024).
DOI:	10.1021/acsomega.4c00290
Abstrakt:	Antithrombotic 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. Competing Interests: The authors declare no competing financial interest. (© 2024 The Authors. Published by American Chemical Society.)
Databáze:	MEDLINE
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