Microparticle Encapsulation of a Tuberculosis Subunit Vaccine Candidate containing a Nanoemulsion Adjuvant via Spray Drying
通过喷雾干燥将含有纳米乳佐剂的结核病亚单位疫苗候选物进行微粒封装
📄 英文摘要 English Abstract
Spray drying is a technique that can be used to stabilize biopharmaceuticals, such as vaccines, within dry particles. Compared to liquid pharmaceutical products, dry powder has the potential to reduce costs associated with refrigerated storage and transportation. In this study, spray drying was investigated for processing an adjuvanted tuberculosis subunit vaccine, formulated as an oil-in-water nanoemulsion, into a dry powder composed of microparticles. Applying in-silico approaches to the development of formulation and processing conditions, successful encapsulation of the adjuvanted vaccine within amorphous microparticles was achieved in only one iteration, with high retention (>90%) of both the antigen and adjuvant system. Moisture-controlled stability studies on the powder were conducted over 26 months at temperatures up to 40°C. Results showed that the powder was physically stable after 26 months of storage for all tested temperatures. Adjuvant system integrity was maintained at temperatures up to 25 °C after 26 months and after one month of storage at 40 °C. The spray-dried product demonstrated improved antigen thermostability when stored above refrigerated temperatures as compared to the liquid product. These results demonstrate the feasibility of spray drying as a method of encapsulating and stabilizing an adjuvanted vaccine.
📄 中文摘要 Chinese Abstract
📋 英文结构化总结 English Structured Summary
摘要整理
Background:
Spray drying is a technique that can be used to stabilize biopharmaceuticals, such as vaccines, within dry particles. Compared to liquid pharmaceutical products, dry powder has the potential to reduce costs associated with refrigerated storage and transportation.
Methods:
In this study, spray drying was investigated for processing an adjuvanted tuberculosis subunit vaccine, formulated as an oil-in-water nanoemulsion, into a dry powder composed of microparticles. Applying in-silico approaches to the development of formulation and processing conditions, successful encapsulation of the adjuvanted vaccine within amorphous microparticles was achieved in only one iteration, with high retention (>90%) of both the antigen and adjuvant system. Moisture-controlled stability studies on the powder were conducted over 26 months at temperatures up to 40°C.
Results:
Results showed that the powder was physically stable after 26 months of storage for all tested temperatures. Adjuvant system integrity was maintained at temperatures up to 25 °C after 26 months and after one month of storage at 40 °C. The spray-dried product demonstrated improved antigen thermostability when stored above refrigerated temperatures as compared to the liquid product.
Data Summary:
High retention (>90%) of both the antigen and adjuvant system was achieved. The powder was physically stable after 26 months of storage for all tested temperatures up to 40 °C. Adjuvant system integrity was maintained at temperatures up to 25 °C after 26 months and after one month of storage at 40 °C.
Conclusions:
These results demonstrate the feasibility of spray drying as a method of encapsulating and stabilizing an adjuvanted vaccine.
Practical Significance:
Compared to liquid pharmaceutical products, dry powder has the potential to reduce costs associated with refrigerated storage and transportation.
📋 中文结构化总结 Chinese Structured Summary
背景:
喷雾干燥是一种可用于将生物制药（如疫苗）稳定化于干燥颗粒中的技术。与液体药物产品相比，干粉具有降低冷藏储存和运输相关成本的潜力。
方法:
本研究探讨了喷雾干燥技术用于将一种佐剂结核亚单位疫苗（配制成水包油型纳米乳剂）加工成由微粒组成的干粉。通过将计算机模拟方法应用于配方和加工条件的开发，仅经过一次迭代即成功实现了佐剂疫苗在定型微粒中的包封，抗原和佐剂系统的保留率均较高（>90%）。在高达40°C的温度下，对粉末进行了为期26个月的湿度控制稳定性研究。
结果:
结果表明，在所有测试温度下，粉末在储存26个月后均保持物理稳定性。佐剂系统的完整性在高达25°C的温度下储存26个月后以及在40°C下储存一个月后均得以维持。与液体产品相比，喷雾干燥产品在高于冷藏温度下储存时表现出更好的抗原热稳定性。
数据总结:
抗原和佐剂系统的保留率均达到较高水平（>90%）。粉末在高达40°C的所有测试温度下储存26个月后均保持物理稳定性。佐剂系统的完整性在高达25°C的温度下储存26个月后以及在40°C下储存一个月后均得以维持。
结论:
这些结果证明了喷雾干燥作为包封和稳定化佐剂疫苗方法的可行性。
实际意义:
与液体药物产品相比，干粉具有降低冷藏储存和运输相关成本的潜力。