McPherson Clifton E
Protein Sciences Corporation, 1000 Research Parkway, Meriden, CT 06540, USA.
Biologicals. 2008 Nov;36(6):350-3. doi: 10.1016/j.biologicals.2008.08.001. Epub 2008 Sep 18.
Influenza is a highly contagious viral respiratory illness which is best prevented through vaccination. Currently, all US licensed influenza vaccines are produced in embryonated chicken eggs. The Baculovirus Expression Vector System (BEVS) technology offers several advantages over existing technology, including an exact match between the circulating virus and the antigen in the vaccine, speed, safety, versatility, and reliable scale-up. The expresSF+ insect cells are grown in the absence of serum and have been extensively qualified for safety according to ICH and US FDA guidance and for suitability for the production of recombinant proteins using BEVS. FluBlok, a recombinant hemagglutinin influenza vaccine, is composed of purified hemagglutinin protein produced using the BEVS technology. FluBlok has been shown to be safe, effective, and efficacious in human clinical studies.
流感是一种极具传染性的病毒性呼吸道疾病,通过接种疫苗可得到最佳预防。目前,美国所有获批的流感疫苗均在鸡胚中生产。杆状病毒表达载体系统(BEVS)技术相较于现有技术具有诸多优势,包括循环病毒与疫苗中的抗原完全匹配、速度快、安全性高、通用性强以及可可靠地扩大规模。expresSF+昆虫细胞在无血清条件下生长,并且根据国际人用药品注册技术协调会(ICH)和美国食品药品监督管理局(US FDA)的指导原则,已在安全性方面得到广泛验证,且适用于使用BEVS生产重组蛋白。FluBlok是一种重组血凝素流感疫苗,由使用BEVS技术生产的纯化血凝素蛋白组成。在人体临床研究中,FluBlok已被证明是安全、有效且有疗效的。