基于减毒和灭活病毒的疫苗

病毒疫苗包括灭活的病毒疫苗和减毒活病毒疫苗。这两种疫苗均依赖于传统的方法生产,即该致病病毒已经被发现并在生物反应器中进行了生产及纯化。这种类型的策略已经成功用于预防多种疾病,目前大多数预防病毒性疾病的疫苗均使用该策略生产。然而,该方法也有它需要克服的挑战: 

  •     确保病毒能够在生物反应器中生产
  •     寻找到正确的宿主细胞
  •     设计对每种疾病定制工艺
  •     符合高生物安全水平下的生产要求,以保护操作员和环境

我们,赛多利斯,理解疫苗研发者以及病毒疫苗生产者的需求,并已经开发了专门的解决方案工具箱。

灭活病毒疫苗

灭活病毒疫苗在疫苗市场中占有重要的地位,其中以流感和脊髓灰质炎疫苗为主。除了新疫苗开发,工艺转移、产能扩大和连续改善也能在这一领域带来积极的改变,采用技术开发更安全、更高效的工艺,有助于降低总体成本。

我们邀请您发现赛多利斯专用于灭活病毒疫苗生产和纯化的技术工具箱。在您探索包膜病毒(例如SARS-CoV-2)、非包膜病毒和特定病毒(例如流感和脊髓灰质炎疫苗)的通用工艺概览时,您可点击每个步骤查看制造商在灭活病毒疫苗工作中面临的挑战——并发现赛多利斯如何提供独特的解决方案来满足这些需求。您还将看到有关工艺步骤可用技术的相关文献。

联系疫苗专家

通用灭活病毒

细胞系/菌株选择 

种子扩增

病毒增殖

澄清

生物负载减低

浓缩/透析

病毒捕获层析

精纯层析

灭活/裂解

浓缩/透析

除菌过滤

其他技术

病毒定量,即在规定体积内测量病毒颗粒浓度,是开发病毒载体时所需要的宝贵信息,要求尽可能地实现实时测量。现有的技术均有局限性,因此需要采用互补性的新技术来确保快速且准确的定量。

Need

Solution

Virus infectivity tests can take days or weeks to get results – rapid detection analytics are needed to address that critical issue

ELISA and PCR methods are faster than infectivity tests, but there is a higher incidence of error variability since they measure virus building blocks and derive total titers from these numbers, leading to a need for alternative, reliable analytics

Situations often demand ready-to-use analytics, but ELISA and PCR need development and validation time to ensure method robustness

A lot of virus samples are generated during process development and manufacturing of viral based vaccines, highlighting the need for an easier workflow allowing rapid quantification of virus samples

The Virus Counter® Platform, a unique and rapid virus quantification method, is the only system able to directly quantify assembled viruses (protein and nucleic acids) for real-time insight

  • Real-time quantification for process monitoring and production optimization can deliver a single sample measurement in three minutes
  • Total viral particle quantification
  • High-specificity and universal ready-to-use quantification reagents
  • The Combo Dye® reagent enables measurement of all enveloped viruses  
  • The Virotag® (antibody-based reagent) enables measurement of specific viruses
  • Software-assisted system operation and data analysis limits the risk of variability


先进的化学计量学方法,例如实验设计(DOE)和多变量数据分析(MVDA),最大限度可视化数据,不仅能节约成本外,同时还能提高工艺的可靠性和稳健性。

需求

解决方案

质量源于设计(QbD)依赖于DoE来了解关键工艺参数,而后者取决于很多实验的实施——这个工具可帮助设计和规划实验,以帮助减轻负担

工艺分析技术产生了大量难以分析的数据,因此对评价历史数据的工具的需求巨大,以便识别相关性、进行故障排除并获得工艺理解   

大多数疫苗开发商和制造商并不是统计学家,而是依赖于用户友好型界面和软件

Umetrics®套件包括三种为工艺开发人员和制造商设计的用户友好型直观软件解决方案,以支持独特的数据可视化、广泛的向导功能和可定制绘图期间的数据分析,从而最大限度地提高可用性和多功能性

  • MODDE® is an advanced, high-quality DOE solution designed for ease of use. The benefit of DOE is to gain knowledge and estimate the best operating conditions of a process or product, and with MODDE® ® the graphical interface and analytics support make it easy to interpret results with complete confidence  
  • SIMCA® Multivariate Data Analysis (MVDA) software is used for scale and batch-to-batch comparison investigations. SIMCA® transforms data into visual information for easy interpretation, enabling decisions and actions to be taken rapidly and with confidence. SIMCA® helps to analyze process variations, identify critical parameters and predict final product quality. An overview of the process status can be obtained in a few clicks  
  • SIMCA® online is a highly efficient software for real-time multivariate statistical process monitoring & control. SIMCA®-online provides a complete set of interactive and visual monitoring tools to production teams, to ensure that batch and continuous operations run smoothly

These software solutions are fully integrated in most Sartorius systems and are available as stand-alone programs


采用日益发展且集成一次性传感器的一次性技术,不仅能实时收集和分析数据,还能提高工艺效率、降低污染风险、提高操作人员的安全性并提高总体产品产量。

需求解决方案

Vaccine manufacturers want to better understand and control their processes, which are very complex and highly regulated, but to do so requires real-time measurement of critical process parameters to allow process monitoring, set-point control (feed control and bleed control), event time point predictions (harvest and infection) and timely identification of process deviations  

A range of PAT sensors would be required to effectively apply QbD principles and ensure consistency in product quality and quantity, quickly identifying and correcting process deviations to reduce the risk of lost batches

The ability to integrate PAT into single-use systems would mitigate risk of spillages and contamination during sampling

BioPAT® toolbox, an expending range of fully qualified single-use sensors, are integrated across the Sartorius portfolio making Sartorius the market leader for PAT

  • Available in process development and manufacturing technologies for full process understanding, monitoring and control
  • Data analysis is straightforward thanks to the full integration in the Sartorius products & technologies  
  • BioPAT® Viamass for inline monitoring of viable cell density and automated cell bleed control
  • BioPAT® Trace for online monitoring of glucose and lactate and automated feed control
  • BioPAT® Xgas for inline monitoring of CO2 and 02
  • BioPAT® Spectro platform for Raman spectroscopy integration in Ambr® and STR bioreactor systems for non-invasive, inline measurement of multiple analytes

Application Data:

减毒活病毒疫苗

由于分子生物学和基因工程领域的快速发展,新一代的减毒活病毒疫苗也即将问世。针对流感等病毒的疫苗,以及登革热或呼吸道合胞病毒(RSV)等较新的应用,都在这一前景广阔的研究领域范围内。快速发展领域通常需要创新技术来跟上新的工艺,以不断提高安全性和生产率。 

我们邀请您发现赛多利斯专用于灭活病毒疫苗生产和纯化的技术工具箱。在您探索包膜病毒(例如SARS-CoV-2)、非包膜病毒和特定病毒(例如流感和脊髓灰质炎疫苗)的通用工艺概览时,您可点击每个步骤查看制造商在灭活病毒疫苗工作中面临的挑战——并发现赛多利斯如何提供独特的解决方案来满足这些需求。您还将看到有关工艺步骤可用技术的相关文献。


联系疫苗专家

通用减毒病毒

细胞系/菌株选择 

种子扩增

病毒增殖

澄清

生物负载减低

浓缩/透析

病毒捕获层析

精纯层析

浓缩/透析

除菌过滤

其他技术

病毒定量,即在规定体积内测量病毒颗粒浓度,是开发病毒载体时所需要的宝贵信息,要求尽可能地实现实时测量。现有的技术均有局限性,因此需要采用互补性的新技术来确保快速且准确的定量。

Need

Solution

Virus infectivity tests can take days or weeks to get results – rapid detection analytics are needed to address that critical issue

ELISA and PCR methods are faster than infectivity tests, but there is a higher incidence of error variability since they measure virus building blocks and derive total titers from these numbers, leading to a need for alternative, reliable analytics

Situations often demand ready-to-use analytics, but ELISA and PCR need development and validation time to ensure method robustness

A lot of virus samples are generated during process development and manufacturing of viral based vaccines, highlighting the need for an easier workflow allowing rapid quantification of virus samples

The Virus Counter® Platform, a unique and rapid virus quantification method, is the only system able to directly quantify assembled viruses (protein and nucleic acids) for real-time insight

  • Real-time quantification for process monitoring and production optimization can deliver a single sample measurement in three minutes
  • Total viral particle quantification
  • High-specificity and universal ready-to-use quantification reagents
  • The Combo Dye® reagent enables measurement of all enveloped viruses  
  • The Virotag® (antibody-based reagent) enables measurement of specific viruses
  • Software-assisted system operation and data analysis limits the risk of variability


先进的化学计量学方法,例如实验设计(DOE)和多变量数据分析(MVDA),最大限度可视化数据,不仅能节约成本外,同时还能提高工艺的可靠性和稳健性。

需求

解决方案

质量源于设计(QbD)依赖于DoE来了解关键工艺参数,而后者取决于很多实验的实施——这个工具可帮助设计和规划实验,以帮助减轻负担

工艺分析技术产生了大量难以分析的数据,因此对评价历史数据的工具的需求巨大,以便识别相关性、进行故障排除并获得工艺理解   

大多数疫苗开发商和制造商并不是统计学家,而是依赖于用户友好型界面和软件

Umetrics®套件包括三种为工艺开发人员和制造商设计的用户友好型直观软件解决方案,以支持独特的数据可视化、广泛的向导功能和可定制绘图期间的数据分析,从而最大限度地提高可用性和多功能性

  • MODDE® is an advanced, high-quality DOE solution designed for ease of use. The benefit of DOE is to gain knowledge and estimate the best operating conditions of a process or product, and with MODDE® ® the graphical interface and analytics support make it easy to interpret results with complete confidence  
  • SIMCA® Multivariate Data Analysis (MVDA) software is used for scale and batch-to-batch comparison investigations. SIMCA® transforms data into visual information for easy interpretation, enabling decisions and actions to be taken rapidly and with confidence. SIMCA® helps to analyze process variations, identify critical parameters and predict final product quality. An overview of the process status can be obtained in a few clicks  
  • SIMCA® online is a highly efficient software for real-time multivariate statistical process monitoring & control. SIMCA®-online provides a complete set of interactive and visual monitoring tools to production teams, to ensure that batch and continuous operations run smoothly

These software solutions are fully integrated in most Sartorius systems and are available as stand-alone programs


采用日益发展且集成一次性传感器的一次性技术,不仅能实时收集和分析数据,还能提高工艺效率、降低污染风险、提高操作人员的安全性并提高总体产品产量。

需求解决方案

Vaccine manufacturers want to better understand and control their processes, which are very complex and highly regulated, but to do so requires real-time measurement of critical process parameters to allow process monitoring, set-point control (feed control and bleed control), event time point predictions (harvest and infection) and timely identification of process deviations  

A range of PAT sensors would be required to effectively apply QbD principles and ensure consistency in product quality and quantity, quickly identifying and correcting process deviations to reduce the risk of lost batches

The ability to integrate PAT into single-use systems would mitigate risk of spillages and contamination during sampling

BioPAT® toolbox, an expending range of fully qualified single-use sensors, are integrated across the Sartorius portfolio making Sartorius the market leader for PAT

  • Available in process development and manufacturing technologies for full process understanding, monitoring and control
  • Data analysis is straightforward thanks to the full integration in the Sartorius products & technologies  
  • BioPAT® Viamass for inline monitoring of viable cell density and automated cell bleed control
  • BioPAT® Trace for online monitoring of glucose and lactate and automated feed control
  • BioPAT® Xgas for inline monitoring of CO2 and 02
  • BioPAT® Spectro platform for Raman spectroscopy integration in Ambr® and STR bioreactor systems for non-invasive, inline measurement of multiple analytes

Application Data:

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