病毒疫苗生产
灭活和减毒活病毒的工艺链
推荐类别
解冻并扩增细胞和种子
将来自工作细胞库或主细胞库的冷冻细胞解冻并扩增，以增加其数量，为后续处理步骤做准备。
培养基和接种物制备
利用适合细胞生长和病毒生产的营养物质、补充剂和 pH 环境对细胞培养基进行优化。
细胞生长和病毒生产
细胞在生物反应器或其他特定条件下的受控环境中生长，以最大限度地提高病毒产量。
细胞裂解
在 AAV 生产过程中，通过化学或机械方法裂解宿主细胞，使病毒释放到培养基中。
DNA 消化
使用核酸酶消化不需要的全细胞和质粒 DNA。
相关文章
- See how the Sf9 rhabdovirus-free cell line was developed and how we’ve developed a companion chemically-defined insect cell media for protein and viral expression.
- Scaling up viral vector production using adherent cell culture systems is challenging. Learn how suspension cell culture systems benefit large-scale bioprocessing.
- A step-by-step overview of suspension-based, transient transfection bioreactor process development and scaleup of lentivirus production.
- To address scalability challenges of AAV manufacturing, we developed an HEK293 suspension cell line that can be used across many serotypes. Get the data in this article.
- Read our white paper on the development of a novel cell culture medium for AAV production with multiple HEK293 lineages and process optimization.
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相关文件
- Product Guide: Upstream Chemicals for Bioprocessing
We offer a broad portfolio of raw materials and chemical components suitable for cell culture media formulations and upstream applications used in biopharmaceutical production.
- White Paper: Application of the Sf-Rhabdovirus-Negative (Sf-RVN®) Platform for AAV Production
The Sf-RVN® Platform is a two-part system comprising a proven Sf-9 cell line devoid of Sf-rhabdovirus (the Sf-RVN® cell line) and a chemically defined medium engineered for the cell line, the EX-CELL® CD Insect Cell Medium.
- Brochure: Gene Therapy Capabilities for AAV and Lentivirus Production
Our products and services for AAV, Lentivirus and other viral vectors provide solutions to your most challenging pain points around process development, speed, manufacturing and regulatory guidelines.
- Transcript: Exploring the Potential of Insect Cell Lines for Efficient AAV Production
Interview transcript with GTRI and their findings of using the Sf-RVN® Platform.
相关视频
Benzonase®核酸酶能将 DNA 和 RNA 有效酶解成小于 5 碱基对的片段。
从工艺放大到克服监管障碍，再到快速投产。
从一开始就运用平台工艺，成功放大基因治疗生产规模。
提高基因治疗和疫苗的安全性
相关网络研讨会
用于基因治疗的 AAV 病毒载体的上游生产面临着独特挑战。了解我们的 HEK 平台是如何克服这些挑战的。
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相关技术文章
- Learn more one the attenuated viral vaccines manufacturing process: cell culture, clarification, nuclease treatment, chromatography, and sterile filtration.
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- Cost Modeling Vaccine Manufacturing: Estimate Production Costs for mRNA and other Vaccine ModalitiesA custom-designed cost model is used to explore the economics of vaccine manufacturing across several different modalities including mRNA. The model enables greater process understanding, simulates bottlenecks, and helps to optimize production efficiency.
- Adjuvant selection for vaccine formulation considers safety, effectiveness, and other characteristics for optimal application.
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查找更多文章和实验方案
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。
生物工艺液体细胞培养基和缓冲液
我们可提供行业内高品质的无菌过滤液，凭借遍布全球的GMP基地供应各种即用型细胞培养基、缓冲液、CIP和SIP产品，助您优化生物制药生产。
制成品无菌过滤和灌装
消除交叉产品污染问题，同时简化灌装和封口要求并遵守现行监管要求。
相关资源
- 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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