Custom assay development based on iLite gives our clients exclusive features, such as:
Thus, the iLite technology provides a single seamless solution for accelerating drug development and reducing costs.
Both FDA and EMA recommend bioassays for immunogenicity assessment 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.)
“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.)
The iLite technology has been used to develop custom assays for corporate partners for more than 15 years. Thus, drug-responsive reporter gene cell lines have been developed for cytokines such as interferon alpha and interferon beta, IL-6, IL-12, and IL-23 and growth factors such as G-CSF, GM-CSF and insulin. Reporter gene assays have also been developed for the quantification of the potency of TNF-alpha antagonists and a number of monoclonal antibodies with targets ranging from Wnt, CD6, and TLR-4, to VEGF. A dual reporter gene assay has also been developed for the quantification of the ADCC activity of monoclonal antibodies such as rituximab.
Development of the custom designed cell line
Project timeline: 3-6 months (dependent on the complexity of the specific project).