The interaction between the reporter gene effector cell and the target cell, generated by the crosslinking of the two cells via a specific drug antibody.
The resulting luminescence originates exclusively from this crosslinking and the signaling from the CD32 receptor to the Firefly Luciferase promoter.
The strength of the luminescence correlates to the drugs ability to induce ADCP.
Increasing evidence suggests that antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) plays a significant role in antibody-mediated protection and control of viral infection and several laboratory methods exist for determining the efficacy of antibodies or effector cells in eliciting ADCC and ADCP
The iLite ADCP Reporter Bioassay is designed for evaluating ADCP of therapeutic monoclonal antibodies (mAbs) and exhibits greatly reduced variability and offers an easier workflow than traditional ADCP assays.
It is an ideal assay for applications such as potency lot release and antibody screening, as well as for assessing comparability between innovator and biosimilars. Furthermore, the bioassay can be used to assess the impact of post-translational modifications, such as glycosylation and fucosylation, on the potency of monoclonal antibodies (mAbs).
Many therapeutic monoclonal antibodies (mAbs) include ADCP as part of their mechanism of action (MoA). This makes accurate determination of ADCP activity an essential part of the development and characterization of therapeutic antibodies.
Using the iLite® ADCP Solution enables the researchers to use only one platform for screening a large pool of compounds to establish a mechanism of action/ effect on target.
iLite ADCP cell lines can successfully be used:
When investigating potential drug candidates, it is essential to determine the presence of ADCP activity and if found, quantify the activity. This is an important step in identifying the most potent antibody and in lot release testing. If ADCP has been determined to be the mechanism of action of a biological drug this should be reflected in the potency assay.
iLite cell lines can be successfully used to:
To increase the ADCP activity of therapeutic antibodies, the pharmaceutical industry has structurally improved the Fc region of the antibodies. Point mutations or modifications into the glycosylation profiles of Fc regions have been shown to increase their affinity towards Fc receptors on a range of effector cells.
With many of the existing patents of monoclonal antibody blockbuster drugs set to expire in the next few years, the development of biologic therapeutics similar to the original drug (biosimilars) has become increasingly important.
However, extensive requirements for analytical characterization are needed to show comparability between innovator and biosimilar and it must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”. This is the biosimilar development approach from the EMA, FDA, and WHO.
The most critical evaluation is that of biological function, through assays that replicate the likely mechanism of action in vivo, with ADCC/ADCP assessments forming an important component.
There are strict requirements to show comparability between innovator drugs and biosimilars. ADCC adn ADCP evaluation studies are an essential part of the comparability profile. It is generally accepted that the innovator and biosimilar will be different due to the complex nature of the production process. However, the regulatory approach is that the compounds must be shown to be sufficiently similar to provide the same clinical outcome when used to treat disease.
Increasing evidence suggests that antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) plays a significant role in antibody-mediated protection and control of viral infection and several laboratory methods exist for determining the efficacy of antibodies or effector cells in eliciting ADCC and ADCP
The iLite ADCP Reporter Bioassay is designed for evaluating ADCP of therapeutic monoclonal antibodies (mAbs) and exhibits greatly reduced variability and offers an easier workflow than traditional ADCP assays.
It is an ideal assay for applications such as potency lot release and antibody screening, as well as for assessing comparability between innovator and biosimilars. Furthermore, the bioassay can be used to assess the impact of post-translational modifications, such as glycosylation and fucosylation, on the potency of monoclonal antibodies (mAbs).
Many therapeutic monoclonal antibodies (mAbs) include ADCP as part of their mechanism of action (MoA). This makes accurate determination of ADCP activity an essential part of the development and characterization of therapeutic antibodies.
Using the iLite® ADCP Solution enables the researchers to use only one platform for screening a large pool of compounds to establish a mechanism of action/ effect on target.
iLite ADCP cell lines can successfully be used:
When investigating potential drug candidates, it is essential to determine the presence of ADCP activity and if found, quantify the activity. This is an important step in identifying the most potent antibody and in lot release testing. If ADCP has been determined to be the mechanism of action of a biological drug this should be reflected in the potency assay.
iLite cell lines can be successfully used to:
To increase the ADCP activity of therapeutic antibodies, the pharmaceutical industry has structurally improved the Fc region of the antibodies. Point mutations or modifications into the glycosylation profiles of Fc regions have been shown to increase their affinity towards Fc receptors on a range of effector cells.
With many of the existing patents of monoclonal antibody blockbuster drugs set to expire in the next few years, the development of biologic therapeutics similar to the original drug (biosimilars) has become increasingly important.
However, extensive requirements for analytical characterization are needed to show comparability between innovator and biosimilar and it must be proven that “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency”. This is the biosimilar development approach from the EMA, FDA, and WHO.
The most critical evaluation is that of biological function, through assays that replicate the likely mechanism of action in vivo, with ADCC/ADCP assessments forming an important component.
There are strict requirements to show comparability between innovator drugs and biosimilars. ADCC adn ADCP evaluation studies are an essential part of the comparability profile. It is generally accepted that the innovator and biosimilar will be different due to the complex nature of the production process. However, the regulatory approach is that the compounds must be shown to be sufficiently similar to provide the same clinical outcome when used to treat disease.
