疫苗生产:工艺开发和专业知识
疫苗开发和生产能力
疫苗是针对病原体和其他传染病的最具成本效益的卫生干预措施之一,每年可挽救数百万人的生命,同时改善无数其他人的生活质量。但是,全球需求的增长给疫苗生产商带来了严峻的挑战。每种新的病原体或疾病爆发都会增加所需的疫苗类型和制造方法的种类,从而无法建立可提高整体有效性、安全性和经济性的可靠的处理模板。
从制造角度来看,许多因素都对加快疫苗生产和实现性能目标至关重要。这些因素包括可预测的规模扩大、优化的上游生产率、强大的杂质去除能力、最大限度提高下游回收率、临床应用速度、患者的安全性以及合规性。实现过程的改进可以为以下所述的所有疫苗开发平台带来益处,但该过程需要创新的技术和高水平的应用专业知识。
疫苗生产平台
病毒样颗粒(VLP)疫苗
VLP的生产涉及到基于细胞的病毒衣壳蛋白表达。VLP可在多种异源表达系统中表达,包括哺乳动物细胞培养、杆状病毒/昆虫细胞培养系统、微生物发酵和植物。
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