病毒疫苗製造
相關技術文章
- Learn more one the attenuated viral vaccines manufacturing process: cell culture, clarification, nuclease treatment, chromatography, and sterile filtration.
- Influenza vaccines are commonly made using egg-based and cell-based manufacturing strategies. Find step-by-step information on the manufacturing process for each method.
- 定制設計的成本模型用於探索包括 mRNA 在內的幾種不同模式的疫苗製造的經濟性。該模型可加深對製程的瞭解，模擬瓶頸，並有助於優化生產效率。
- Adjuvant selection for vaccine formulation considers safety, effectiveness, and other characteristics for optimal application.
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Optimize Upstream Productivity and Clarification with Reliable Scale-up
為製造以病毒為基礎的疫苗而開發的上游培養製程必須加以最佳化，以符合生產力需求。
利用可靠的雜質去除實現產量和效率目標
來自裂解細胞的核酸是病毒疫苗製程中常見的污染物。法規要求攜帶的宿主細胞核酸必須低於 10 ng/劑量的減毒病毒疫苗。Benzonase® 內切酶處理後再進行切向流過濾，是一種強而有力的組合，可以降解並去除殘留的核酸成分。
最大化下游回收
在濃縮和重過濾過程中，Benzonase®內切酶處理足以讓大多數病毒基疫苗達到所需的純度。然而，要達到日本腦炎病毒 (JEV) 和登革熱病毒 (DENV) 等新一代病毒型疫苗的純度目標，則需要使用層析技術。
確保病患安全
儘管病毒疫苗是使用減毒病毒製造，確保病患安全仍是重要的考量。最終的病毒疫苗體積與水相當。因此，疫苗可在最後的配制和填充完成步驟前使用 0.22 µm 滅菌過濾器進行滅菌。
生物處理液體細胞培養基及緩衝液
我們提供業界最高品質的無菌過濾液能力，從全球各地的 GMP 設施提供即用型細胞培養基、緩衝液、CIP 和 SIP 產品，以優化您的生物製藥生產。
下游 - 切向流過濾
達到產量、效率和病毒回收目標，同時確保強大的雜質去除能力。
最終無菌過濾與充填
消除產品交叉污染的疑慮，同時簡化灌裝-精加工的要求，並符合目前的法規要求。
分析軟體與 PAT 技術
相關資源
- Application Guide: Biopharmaceutical
A search tool to help you overcome your manufacturing challenges.
- Brochure: Vaccine Bioprocessing Handbook
In this handbook, we explain the vaccine production processes and process improvements for all types of vaccine development platforms.
- Mini-Handbook: Cell-Based Vaccine Bioprocessing
Live attenuated viral vaccines can be created using a complex, multi-step cell-based manufacturing process. It is not a templated process. The manufacturing process for each viral vaccine is different.
- e-Book: Enabling Capabilities & Solutions for all Vaccine Platforms
From process development to full-scale GMP-manufacturing, our global vaccine capabilities can help you achieve these goals for all your modalities/platforms including virus-based, subunit, VLP, viral vector, pDNA and mRNA vaccines.
- White Paper: Filtration Strategies for Optimal Development and Purification of a Foot and Mouth Disease Virus
We collaborated with MEVAC to optimize upstream and downstream processes for FMD vaccine manufacturing to establish a scalable, cost-efficient and GMP compliant process. This white paper focuses on the integration of new filtration strategies in both upstream and downstream processes.
- White Paper: Downstream Process Intensification for Virus Purification Using Membrane Chromatography
This white paper provides an overview of the challenges presented by current approaches to virus production and the opportunities to develop a platform approach that can work across different viral modalities and accelerate process development.
- Application Note: Effect of Benzonase® Endonuclease Addition to Purification of Sabin Polio Virus Type 3
This application note summarizes the benefits of incorporating Benzonase® endonuclease in a polio virus type 3 production process.
- Article: Filter-Based Clarification of Viral Vaccines and Vectors
In this article, a comprehensive overview is provided on different filtration technologies and their application in viral vaccine clarification, outlining challenges and present current best practices.
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