“药”点笔记 | 浅析新冠病毒疫苗研发技术路线及工艺解决方案 (下)
section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box letter-spacing: 1.2px line-height: 1.8 overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " 全球新冠疫情愈演愈烈的背景下,疫苗被寄予彻底终结疫情的厚望。然而,世界卫生组织不止一次强调疫苗的开发很难在18个月内完成。要知道,最近几年人类的疫苗研发往往耗时数年。但这一次,人类必须提速。那么我们要如何优化研发流程才让全球不同背景的研发者都可以跑步前进研发新冠疫苗呢?上期和大家分享了: /span a href=" https://www.instrument.com.cn/news/20200514/538440.shtml" target=" _blank" span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box font-size: 14px text-decoration: underline color: rgb(255, 192, 0) overflow-wrap: break-word !important " strong 浅析新冠病毒疫苗研发技术路线及工艺解决方案 (上) /strong /span /a span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " (点击查看) /span span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " ,本期继续带您了解更多内容。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(86, 86, 86) font-size: 14px letter-spacing: 1.2px " /span br/ /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/c4fced0d-ef6d-4d5e-8747-36a82de56bef.jpg" title=" 001.png" alt=" 001.png" / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(86, 86, 86) font-size: 14px letter-spacing: 1.2px " 关于快速性,可以做个简单的比较: /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 不锈钢配储液工艺,从设计到施工、验收,一般需要一年半到两年时间,甚至更长。而一次性工艺,只需3~6个月。只要厂房水电可用,一次性设备的硬件到货,把袋子组装完成后便可以立即进行生产。尤其在目前新型冠状病毒全球爆发的情况下, strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " 能够快速的进行疫苗生产 /span /strong 就显得尤为重要。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " 在 strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " 灵活性 /span /strong 上,假设工厂里已经有一条一次性的生产线,这时如果要生产其他的疫苗,只需改一些管路,袋子设计,接口等,就能生产新的产品。从生产的角度说,设备转换更为灵活。除此之外,采用病毒灭活工艺制备的新冠疫苗,是在P3厂房进行的,采用一次性产品可以减少清洗容器具废水产生,大大降低了,排废处理的时间和成本。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " & nbsp /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " 至于 span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 安全性 /strong /span 则更加直观。一次性产品完全在密闭容器内,进行溶液的传输,这些溶液中就包括灭活前,大规模发酵的病毒收获液,各步骤含大量病毒纯化中间体。将这些溶液控制在密闭容器中,大大降低了病毒泄漏对操作人员威胁,提高了生物安全。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px " & nbsp /span /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " section style=" margin: 0px padding: 0px 0px 3px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 0px " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 5px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section section style=" margin: -3px auto 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 1px height: 5px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section section style=" margin: -1px -5px 0px padding: 0px 8px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 560px display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 544px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 5px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section section style=" margin: -3px auto 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 1px height: 5px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section /section section style=" margin: 0px 2px 5px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important border-left: 1px solid rgb(217, 217, 217) border-right: 1px solid rgb(217, 217, 217) border-top-color: rgb(217, 217, 217) border-bottom-color: rgb(217, 217, 217) " section powered-by=" xiumi.us" style=" margin: 0px padding: 10px max-width: 100% box-sizing: border-box word-wrap: break-word !important " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important text-align: justify font-size: 14px letter-spacing: 1.2px line-height: 1.8 color: rgb(86, 86, 86) " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " 在一般的疫苗生产过程中,一次性工艺可以应用在培养基的配制、下游缓冲液的配制,制剂灌装环节,还可以进行辅料佐剂的配制以及一次性的制剂灌装线的设计。整个上游到下游,包括无菌的连接和断开,都可以通过一次性技术实现。 /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " 由于上下游的缓冲液和培养基的配制应用相对简单(搅拌、过滤、存储)所以本文会重点分享 span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 制剂灌装环节中一次性产品的优势 /strong /span 。 /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section /section /section section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 0px " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 5px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section section style=" margin: -3px auto 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 1px height: 5px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section section style=" margin: -1px -5px 0px padding: 0px 8px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 560px display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 544px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important display: inline-block vertical-align: middle " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 5px height: 1px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section section style=" margin: -3px auto 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 1px height: 5px background-color: rgb(217, 217, 217) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section /section /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 12px text-align: center color: rgb(160, 160, 160) " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " & nbsp ▼ /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box letter-spacing: 1.2px line-height: 1.9 overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 一般半成品配制后就是分装环节。其中会涉及到不同的储藏方式:有的蛋白需要冻存,有的蛋白则是常温储存或2~8摄氏度储存。制剂灌装时,可以把每个单价原液蛋白拿出来。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 由于每个单价原液的蛋白含量所用的量不一样,可以通过加一步称重从而得到每个单价原液蛋白精确的含量。再将不同价的蛋白分别通过无菌焊接的方式进入半成品配制的袋子里,加上佐剂,就可以进行半成品配制。配制完成后,可以采用OPTA无菌对接方式,跟灌装机里的设备管路进行对接,然后进行灌装。这是多价疫苗制剂灌装的一条线。另一个是4价疫苗,工艺就是通过每个单价,4条线下来,分别过滤后到混匀设备里。第4个单价下来后再汇到总的混匀袋里,跟制剂灌装线灌装机进行对接。整个对接工艺都可以采用无菌接头的方式。对接完成后,便可以进行灌装。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 因此整个流程涉及四类设备,分别是混匀,无菌连接和断开,无菌传输系统,以及灌装系统。 /span /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/55ea616b-aac8-4269-b051-090e23eb6378.jpg" title=" 01.png" alt=" 01.png" / /p br/ /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box font-size: 24px text-align: center overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 混匀 /strong /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important letter-spacing: 1.2px line-height: 1.8 " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " br/ /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 就混匀搅拌系统而言,目前市面上比较常见的有三大类: /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " ■ 上搅拌 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " ■ 磁力搅拌 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " ■ 磁悬浮搅拌 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 上搅拌有个较为突出的问题就是放大性不是很好:例如在3000L的时候,这种方式无论是操作性还是封闭性,都有很大问题,所以逐渐被淘汰了。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 第二类是磁力搅拌,是目前行业里使用最广泛的方案,但它同样存在问题——由于下面有轴封,搅拌的时候会有颗粒物释放,密封性有时候也有问题。而最优方案,就是磁悬浮搅拌。完全的磁耦合悬浮形式因为没有摩擦,颗粒物几乎可以忽略,同时由于搅拌比较温和,所以剪切力也比较低。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " & nbsp /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 这里要介绍一下赛多利斯新的搅拌系统。我们最新一代的搅拌系统 strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " Flexsafe& reg Pro Mixer /span /strong 由三个部分构成: /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 1. span class=" Apple-converted-space" & nbsp /span span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 外框架 /strong /span ,主要起到支撑袋体的作用。支持50L到3000L的体积(涵盖了生物制药的全部规模)。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 2. span class=" Apple-converted-space" & nbsp /span span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 驱动 /strong /span ,通过磁悬浮技术实现混匀驱动,但不同于以往的磁悬浮——是高扭矩高转速的驱动。它的转速最大可以达到750rpm,同时还不需要充磁。用过磁悬浮搅拌系统的人都知道:老式的磁悬浮的系统都需要充磁——使用前要先充半个小时。ProMixer则无需这个步骤。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 3. /span span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 内 /strong /span /span span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 部的搅拌袋膜材 /strong /span ,强大的Flexsafe膜材——赛多利斯最新的膜材。袋体上还可以整合一次性的PH电机和电导电极,可以实现在线参数监测。 /span /p p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/c2cc294c-a439-4c6a-a81c-9017d9e729ef.jpg" title=" 02.png" alt=" 02.png" / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 12px text-align: center letter-spacing: 1.2px line-height: 1.8 color: rgb(160, 160, 160) " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " Flexsafe& reg Pro Mixer 内部结构 /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br/ /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box letter-spacing: 1.2px line-height: 1.8 overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 搅拌系统需要足够强劲的搅拌效率才能保证在上游使用时的搅拌效果。赛多利斯对自己的搅拌系统进行了计算机的流体力学模拟,能够验证搅拌的时候袋体内部情况以及流体动作能否确保混匀的效果。同时我们还会进行实际测试以保障性能。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " & nbsp & nbsp & nbsp /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 除此之外,混匀的过程可能对蛋白活性造成影响。其中主要风险来自剪切力。赛多利斯能够模拟剪切力在搅拌过程中的强度并评估对是否会对产品造成影响。通过对搅拌桨的独特设计——钝角设计且桨叶高度低,ProMixer能够在保证混匀效果的同时将剪切力完全控制在可接受范围内,从而保证蛋白在混匀的时候不会受到影响。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/f9909487-6b4c-42cb-a82b-9265d8a85190.jpg" title=" 03.png" alt=" 03.png" / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 24px letter-spacing: 1.2px line-height: 1.8 " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 无菌连接/断开 /strong /span /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box line-height: 1.8 letter-spacing: 1.2px overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 无菌连接/断开不仅在制剂环节非常重要,整个上下游都会涉及到这部分的技术——例如狂犬疫苗就是从上到下全无菌的工艺。由于产品蛋白不能过滤,整个环节从上游接种开始直到最后制剂灌装的所有过程都会使用到无菌连接/断开。赛多利斯对于无菌连接有两个解决方案: strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " 接管机 /span /strong 和 span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " 无菌接头 /strong /span 。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 赛多利斯接管机的工作原理是将两根管子放到设备里,启动后会有一个加热刀片将管子切断,再采用旋转的方式,将两根切断的管子对接上,冷却,就可以实现无菌焊接。整个过程中,无需任何环境限制,就能够进行全自动的无菌连接。整个过程全自动化,无需担心人为操作的失误。能够应用在上游的接种和培养基的转移,补料,以及下游的全无菌工艺。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 另外就是无菌接头的对接方式。 span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " OPTA无菌对接头 /strong /span 是抽纸式连接器,需要预先安装在管路的出口再进行对接,实现无菌对接。同样对环境没有任何要求。但相对前面还多了两个应用点:一个就是制剂灌装时候的无菌对接——制剂灌装的时候会尽量避免选择加热的方式,因为加热会导致一些析出的风险。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 疫苗行业还好,因为使用的量很少,一个人接种0.5ml,所以可以采用热力式的连接方式。但单抗用于治疗,病人整个疗程下来可能要打多至几百毫升的药物进去——这个时候使用机械式的连接更为安全。第二是可以进行硅胶管的连接。热力式的连接只能是热塑管连接,无菌对接头可以连接普通硅胶管。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/c361b3e9-8cb6-43fc-9104-1a6ad5f38b16.jpg" title=" 04.png" alt=" 04.png" / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 12px text-align: center color: rgb(160, 160, 160) " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " OPTA /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box line-height: 1.8 letter-spacing: 1.2px overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box line-height: 1.8 letter-spacing: 1.2px overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 对应的,赛多利斯也可以提供两种断开方案:一种是热力式的断开,一种是机械式的。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 热力式的断开是使用最新一代的Biosealer & nbsp TC,管子放进去以后会对管子夹紧,加热从而使热塑管熔化粘合在一起。拿下来后用剪刀断开,轻松实现无菌断开。赛多利斯最新一代的无菌封管机目前可以适配OD 1/4到1英寸的管径,适配多种品牌管路。同时都内置好了相应程序,只需切换程序即可断开不同品牌的管路。小巧灵活,可以灵活放置使用操作方式为触屏式。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 无菌连接料液转移完后就可以采用它进行断开。赛多利斯的 strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " Clipster无菌断开器 /span /strong 是全机械的,配合两个断开器,可以对管路任意位置进行断开,快捷方便。机械结构带来极高的可靠性。同样,在制剂环节中也可以用 span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(0, 0, 0) " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " Clipster /strong /span 断开硅胶管路。 /span /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/742ac173-9fe8-49a0-8dc2-8bfdfe38dd6a.jpg" title=" 05.png" alt=" 05.png" / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 12px text-align: center color: rgb(160, 160, 160) " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " Clipster /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/8f820711-0c8b-4be2-ac77-127b0e61c32f.jpg" title=" 06.png" alt=" 06.png" / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br/ /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box line-height: 1.8 letter-spacing: 1.2px overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 24px " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important letter-spacing: 1.2px " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " 无菌传输 /span /strong /span /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br/ /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box line-height: 1.8 letter-spacing: 1.2px overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important color: rgb(86, 86, 86) font-size: 14px letter-spacing: 1.2px " 料液过滤完成后就是灌装的步骤,会涉及到B级到A级或C级到A级的传输工艺——无菌传输系统就显得至关重要。无菌传输系统,严格意义上是隔绝两个级别的目的设计的系统。赛多利斯有两种解决方案:一个是Biosafe,固体和液体都能够传输。内部的开放式管路能够伸到A级环境里,跟灌装管路对接。外部的管路接头是无菌接头,通过跟料液对接,能够把料液顺序传输进去,保持内外隔离状态。除此之外,Biosafe还可以用来传输固体:例如胶塞,或是有QC检测样品要取出——向内向外都可以进行传输。 /span br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 第二套解决方案是SART系统,适用于液体传输。SART系统原理与Biosafe类似,能够在实现完全隔离内外两个级别的环境的条件下实现料液传输。 /span /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width:100% max-height:100% " src=" https://img1.17img.cn/17img/images/202006/uepic/e0e3bedd-0ab3-41fa-9290-3d4f3394d533.jpg" title=" 07.png" alt=" 07.png" / /p br/ /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box font-size: 24px overflow-wrap: break-word !important " 罐装 /span /strong /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br/ /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box letter-spacing: 1.2px line-height: 1.8 overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 料液传输后还需要被灌装到西林瓶或者预充针中。这部分的产品原理上比较简单,就是一个灌装缓冲袋,下面接上了一根根的灌装管路,管路最末端还有灌装针,袋体上方还有进液管,把除菌料液通过进液管进入袋体,从下面每个分支管路进行灌装,实现这样一个功能。设置缓冲袋的目的是为了平衡内外的泵差。袋子的设计会有一些技巧。以赛多利斯的袋子为例,是一个长方形折叠的袋子——折叠最底部再连接上灌装管路。其优点在于折叠后两边会有一部分的液体被均匀平衡地分到两边,从而使得对下方的压力持续保持一致。这种设计能够使得罐装的精度大大提高,还能保证最后的排空率。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 此外,袋子上还有4个呼吸器,作用在于平衡内外压力。密封状态下,灌装造成的液面变化会导致压力的变化,从而影响灌装精度。这4个呼吸器则可以保障压力平衡,提高精度。另外,如果蛋白对氧气敏感,呼吸器则可以用于充入氮气或是惰性气体来对蛋白进行保护。我们还有配套的一次性罐装针,无需再清洗、验证。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " & nbsp /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 14px color: rgb(86, 86, 86) " 由于这个袋子处于整个流程末尾的最高风险环节,赛多利斯在生产时采用最高级别的质检。袋子生产时,每批产品,都额外会生产若干个用于破坏测试。只有在各项指标测完没有任何问题后,这个批次产品才会放行。 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " section style=" margin: 0px 0px -2.25em padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " section style=" margin: 0px padding: 10px max-width: 100% box-sizing: border-box word-wrap: break-word !important background-color: rgb(242, 242, 242) " section powered-by=" xiumi.us" style=" margin: 10px 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " section style=" margin: 0px 0px -0.9em 0.5em padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important height: 1.4em border-left: 1px solid rgb(158, 158, 158) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 2.5em border-top: 1px solid rgb(158, 158, 158) line-height: 0 " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important line-height: 0 width: 0px " svg viewbox=" 0 0 1 1" style=" vertical-align:top " /svg /section /section section style=" margin: 0px padding: 0px 0.5em max-width: 100% box-sizing: border-box word-wrap: break-word !important " section style=" margin: 0px padding: 10px max-width: 100% box-sizing: border-box word-wrap: break-word !important " section powered-by=" xiumi.us" style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important text-align: justify font-size: 14px color: rgb(86, 86, 86) line-height: 1.8 letter-spacing: 1.2px " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " 疫苗是用于健康人的特殊产品,对于新冠疫苗研发,全力以赴,争分夺秒的同时,需要秉持科学精神,尊重科学规律,把疫苗的安全性放在第一位。赛多利斯致力于简化工程师的工作,提供研发生产一站式解决方案。 /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " 我们相信,在科学力量与人类智慧的结合下,疫苗这一战胜新冠肺炎疫情的“终极武器”,一定会早日到来! /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em white-space: normal overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section /section /section section style=" margin: 0px 0px 0px auto padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 2.5em " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 2.5em border-top: 1px solid rgb(158, 158, 158) line-height: 0 " section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important line-height: 0 width: 0px " svg viewbox=" 0 0 1 1" style=" vertical-align:top " /svg /section /section section style=" margin: -0.9em 0px 0px 2em padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important height: 1.4em border-left: 1px solid rgb(158, 158, 158) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section /section /section /section section style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important width: 2.25em height: 2.25em border-bottom: 5px solid rgb(253, 236, 79) border-left: 5px solid rgb(253, 236, 79) transform: rotate(0deg) line-height: 0 " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /section /section section powered-by=" xiumi.us" style=" margin: 30px 0px 20px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" text-align: center" img style=" max-width: 100% max-height: 100% width: 51px height: 51px " src=" https://img1.17img.cn/17img/images/202006/uepic/9fb39060-a369-49c3-86df-b993c20038a1.jpg" title=" 08.jpg" alt=" 08.jpg" width=" 51" height=" 51" / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box text-align: center overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " strong style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 赛多利斯研习社-“药”点笔记 /span /strong /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box !important word-wrap: break-word !important " / /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 紧跟时代药点 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 我们提供最前沿的技术趋势与行业洞察 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " & nbsp /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 想要了解更多生物工艺技术干货或更多行业动态 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 请持续关注赛多利斯生物工艺 /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " span style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important font-size: 15px " 我们与你线上共聚! /span /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em overflow-wrap: break-word !important " br style=" margin: 0px padding: 0px max-width: 100% box-sizing: border-box word-wrap: break-word !important " / /p /section section powered-by=" xiumi.us" style=" margin: 0px padding: 0px 1em max-width: 100% box-sizing: border-box overflow-wrap: break-word !important " p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em text-align: center white-space: normal overflow-wrap: break-word !important " ———— /p 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https://www.instrument.com.cn/news/20200514/538440.shtml" target=" _blank" textvalue=" “药”点笔记 | 浅析新冠病毒疫苗研发技术路线及工艺解决方案 (上)" style=" color: rgb(255, 192, 0) text-decoration: underline " “药”点笔记 | 浅析新冠病毒疫苗研发技术路线及工艺解决方案 (上) /a /span /strong /p p style=" margin-top: 0px margin-bottom: 0px padding: 0px max-width: 100% box-sizing: border-box clear: both min-height: 1em color: rgb(51, 51, 51) font-family: -apple-system-font, BlinkMacSystemFont, " helvetica=" " pingfang=" " hiragino=" " sans=" " microsoft=" " yahei=" " letter-spacing:=" " text-align:=" " white-space:=" " background-color:=" " overflow-wrap:=" " break-word=" " strong style=" color: rgb(255, 192, 0) text-decoration: underline " br/ /strong /p /section /section p style=" text-align: right text-indent: 0em " span style=" color: rgb(165, 165, 165) " 文 |& nbsp 赛多利斯工艺平台专家团队 /span /p