Anitua Eduardo, Reparaz Iraia, de la Fuente María, Hamdan Alkhraisat Mohammad
Regenerative Medicine Laboratory, BTI-Biotechnology Institute, 01007 Vitoria, Spain.
University Institute for Regenerative Medicine and Oral Implantology-UIRMI (UPV/EHU-Fundación Eduardo Anitua), 01007 Vitoria, Spain.
Biomedicines. 2025 May 1;13(5):1105. doi: 10.3390/biomedicines13051105.
: To evaluate the sterility and biological functionality of platelet lysate eye drops stored in BTI ophthalmic devices for PRGF delivery under different storage conditions and simulated use scenarios. : Eye drops were prepared using platelet lysate and stored in BTI tubes under three different conditions: ≤-15 °C, 2-8 °C, and room temperature (RT) for 72 h. Simulated use was performed for 72 h with controlled drop dispensing. Bacterial contamination was assessed according to European Pharmacopoeia sterility testing principles. The biological activity of the eye drops was assessed using in vitro proliferation assays with primary human keratocytes (HKs) and human corneal epithelial cells (HCEs). Statistical analyses were performed to compare the effects of different storage conditions and application scenarios. : No bacterial contamination was detected in platelet lysate eye drops stored under any of the conditions tested, regardless of simulated use. Proliferation assays showed that eye drops enhanced the growth of HK and HCE cells compared to the control medium. No significant differences in proliferation were observed between storage conditions. : Platelet lysate eye drops maintain sterility and biological functionality when stored in BTI ophthalmic devices at ≤-15 °C, 2-8 °C and RT for up to 72 h of simulated use. These results support the feasibility of using BTI eye drop devices in clinical settings while ensuring safety and efficacy.
评估在不同储存条件和模拟使用场景下，储存在用于PRGF递送的BTI眼科装置中的血小板裂解液滴眼液的无菌性和生物学功能。：使用血小板裂解液制备滴眼液，并在三种不同条件下储存在BTI管中：≤-15°C、2-8°C和室温（RT）下保存72小时。通过控制滴注进行72小时的模拟使用。根据欧洲药典无菌测试原则评估细菌污染情况。使用原代人角膜细胞（HKs）和人角膜上皮细胞（HCEs）的体外增殖试验评估滴眼液的生物学活性。进行统计分析以比较不同储存条件和应用场景的影响。：在任何测试条件下储存的血小板裂解液滴眼液中均未检测到细菌污染，无论是否进行模拟使用。增殖试验表明，与对照培养基相比，滴眼液可促进HK和HCE细胞的生长。在储存条件之间未观察到增殖的显著差异。：当储存在BTI眼科装置中时，血小板裂解液滴眼液在≤-15°C、2-8°C和室温下保存长达72小时的模拟使用期间可保持无菌性和生物学功能。这些结果支持在临床环境中使用BTI滴眼液装置的可行性，同时确保安全性和有效性。
