There is a growing need for bioassays that can accurately characterize the various aspects of biopharmaceutical drugs in the pharmaceutical industry. Developing these bioassays is a complex and rigorous process that involves addressing multiple challenges, such as modeling the mechanisms of action associated with biotherapeutics and ensuring the development of robust and validatable assays.
Assay-ready reporter gene assays are an invaluable tool in assessing both functionality and representing the mode of action (MOA) in bioassays.
In this poster, we have outlined a set of assays by which the performance of cell-based reporter gene assays can be determined and validated. To ensure that the assays are reliable, accurate, and reproducible and that errors resulting from biological variation and methodology are kept to a minimum.
There is a growing need for bioassays that can accurately characterize the various aspects of biopharmaceutical drugs in the pharmaceutical industry. Developing these bioassays is a complex and rigorous process that involves addressing multiple challenges, such as modeling the mechanisms of action associated with biotherapeutics and ensuring the development of robust and validatable assays.
Assay-ready reporter gene assays are an invaluable tool in assessing both functionality and representing the mode of action (MOA) in bioassays.
In this poster, we have outlined a set of assays by which the performance of cell-based reporter gene assays can be determined and validated. To ensure that the assays are reliable, accurate, and reproducible and that errors resulting from biological variation and methodology are kept to a minimum.
Assay-ready reporter-gene assays are essential tools in the development of biopharmaceuticals. Their important functions as a critical reagents in many pivotal bioassays mean they must perform well and consistently over time and under different experimental settings.
The aspect evaluated can be divided into three main themes:
• Cell line validation
• Bioassay Application Characterization
• Clinical Immunogenicity Characterization
Here, we have presented a set of procedures that can be used to assess the performance of assay-ready reporter-gene assays and
subsequent results we have obtained using the iLite Functional Bioassays.
Following these guidelines in developing and subsequently characterizing cell-based bioassays ensures the assay can generate consistent data over time and in different environments.