The iLite technology, based on a reporter gene assay format, provides a seamless solution for applications extending across the whole drug development process, as well as for monitoring of biological drugs.
The technology can be developed for virtually any pharmaceutical target and allows an easy, rapid and accurate test format for measurement and quantification of drug activity and immunogenicity. The cells are supplied in an Assay Ready Format, removing the need for cell-culturing and allowing a seamless transfer of the assay between departments or to third party collaborators.
By combining unique features such as a normalization readout and chimeric transcription factors with a highly flexible product format, the iLite technology helps you make the most of your bioassay.
When a ligand binds to its receptor, a specific intracellular signaling pathway is activated, triggering the transcription of a specific reporter gene construct coding for luciferase. When a substrate is added, the luciferase generates light, and the amount of luciferase and thereby the amount and activity of the ligand can then be measured as light emission using a luminometer.
A unique feature of the iLite cells is that they also contain a second reporter gene which is under the control of a constitutive promoter, meaning that it is expressed continuously in any living cell. In other words, the amount of light generated from this second reporter gene will be correlated to the number of living cells, and can therefore be used for normalizing results to compensate for differences in cell number.
Having the right tools for assessing your drug is key to accelerating your path to market.
Both FDA and EMA recommend the use of bioassays during drug development:
“Generally FDA considers that bioassays are more reflective (than competitive ligand-binding assays) of the in vivo situation and are recommended” (Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, issued by FDA, Dec 2009.)
“Ideally, the potency assay will represent the product's mechanism of action (i.e., relevant therapeutic activity or intended biological effect)” (Guidance for Industry: Potency for cellular and gene therapy products, issued by FDA, Jan 2011)
“For most biological products, the most appropriate neutralizing antibody assay is a bioassay which measures the neutralization of the bioactivity” (EMA Guidance on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, issued by EMA, 2012.)