病毒疫苗生产
![灭活和减毒活病毒的工艺链 灭活和减毒活病毒的工艺链](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/process-train-inactivated-live-vttenuated-virus/process-train-inactivated-live-vttenuated-virus.jpg)
灭活和减毒活病毒的工艺链
相关资源
通过可靠的扩大化优化上游生产力和澄清工艺
为满足生产力要求,必须对针对生产病毒疫苗而开发的上游培养工艺进行优化。该优化涉及澄清步骤,对于去除细胞和细胞碎片并确保稳健的病毒收集至关重要。 然而,只有能够针对预期市场需求进行可靠扩大化的上游工艺才能成功。
通过稳健地去除杂质实现产量和效率目标
来自裂解细胞的核酸是病毒疫苗生产工艺常见的一种污染物。监管规定要求残留的宿主细胞核酸水平需低于10 ng/减毒疫苗剂量。Benzonase®核酸内切酶处理以及随后的切向流过滤是一种稳健而强大的组合,可降解和去除残留的核酸成分。
最大限度提高下游回收率
在浓缩和渗滤过程中,Benzonase®核酸内切酶处理可实现大多数病毒疫苗所需的纯度水平。然而,新一代病毒疫苗(例如日本脑炎病毒(JEV)和登革热病毒(DENV))的纯度目标则需要通过层析来实现。由于每一道生产工艺都必须根据病毒的特征进行定制,因此下游纯化选项的工具箱对于实现所需的纯度、最大限度提高回收率至关重要。
确保患者安全
尽管病毒疫苗是使用减毒病毒生产的,但确保患者的安全仍然是重点。最终的病毒疫苗批量与水相当。因此,在最终配制和灌装完成步骤之前,可使用0.22 µm无菌过滤对疫苗进行灭菌。
工作流程
![Upstream Cell Culture Upstream Cell Culture](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/conjugation/conjugation.png)
![Nuclease Treatment & Clarification Nuclease Treatment & Clarification](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/sterile-filtration/sterile-filtration.png)
![Bioprocessing Liquid Cell Culture Media & Buffers Bioprocessing Liquid Cell Culture Media & Buffers](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/liquid-cell-culture-media/liquid-cell-culture-media.png)
生物工艺液体细胞培养基和缓冲液
We offer the industry’s highest quality sterile filtered liquid capabilities, supplying ready-to-use cell culture media, buffers, CIP and SIP products from GMP facilities worldwide to optimize your biopharma production.
![Downstream - Tangential Flow Filtration Downstream - Tangential Flow Filtration](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/membrane_barrier/membrane_barrier.png)
下游 - 切向流过滤
Achieve yield, efficiency and virus recovery goals while ensuring robust impurity removal
![Downstream Chromatography Downstream Chromatography](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/chromatography/chromatography.png)
![Process Chemicals and Formulation Process Chemicals and Formulation](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/formulation/formulation.png)
制成品无菌过滤和灌装
Remove cross product contamination concerns while streamlining fill-finishing requirements and complying with current regulatory requirements
![Validation & Testing Services Validation & Testing Services](/deepweb/assets/sigmaaldrich/marketing/global/images/applications/pharma-and-biopharma-manufacturing/vaccine-manufacturing/clipboard_filter/clipboard_filter.png)
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