增加细胞和基因治疗的生产率,具有快速可靠的免疫测定的生物加工

细胞和基因治疗制造商需要确保其产品的安全交付,并依赖于快速可靠的免疫分析平台。

This white paper gives an overview of the viral vector landscape and the requirements for immunoassays in viral vector bioprocessing analytical workflow. It also shares case studies from viral vector labs that are using the Gyrolab technology to deliver fast and reliable results.

增加细胞和基因治疗的生产率,具有快速可靠的免疫测定的生物加工

及时释放安全和有效的细胞和基因治疗剂取决于许多因素。一个是分析平台的可用性,可以快速提供有关病毒滴度和过程相关的杂质的可靠数据。

There are many factors to consider when choosing an platform to ensure high productivity. The system must be robust and quickly generate reliable data from small amounts of precious sample. It should enable rapid method development and still provide flexibility to support the development of novel assays.

Automation and a walk-away systems are essential to reducing hands-on-time and minimizing manual errors, enabling personnel to spend time on more important tasks. Added to that, ready validation and a software that enables 21 CFR Part 11 compliance is a must to meet regulatory guidelines.

We will investigate the needs of immunoassays in bioprocess analytics for cell and gene therapy in detail and how increased productivity can be met.

Immunoassays such as ELISA are frequently used to measure critical quality attributes, such as virus titer and impurity levels, but can be laborious and consume large amounts of precious sample.

Gyrolab小型化免疫测定技术提供了一种强大的自动替代方案,可以产生与ELISA相当的数据,但随着动手较低的时间,较低的珍贵样品和试剂的消耗,以及最小的矩阵干扰。它还提供更高的精度,以及更广泛的动态范围,可减少再分析的需求。Gyrolab软件支持21个CFR部分11,从而符合系统符合QC实验室等调节环境中的。下面的示例显示与手动ELISA(橙色线)相比,Gyrolab(蓝线)上AAV9滴度测定的动态范围增加。

Thiswhite paper概述了病毒载体景观及其在细胞和基因治疗中的用途,重点是慢病毒载体和腺相关病毒(AAV)载体。详细讨论了病毒载体生物过程分析中免疫测定中的要求,并提出了来自病毒载体分析实验室的Gyrolab案例研究。了解在生物过程分析工作流程中实现Gyrolab技术时,有多少实验室正在经历提高的生产率。

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