Custom Assay Development - for any Biopharmaceutical target

The iLite® technology is used extensively by a number of major pharmaceutical- and numerous biotechnology companies for the quantification of drug potency and detection of neutralizing antibodies (NAbs).

Custom assay development based on iLite gives our clients exclusive features, such as:

  • Cell lines developed to give high specificity and no unwanted cross-reactivity.
  • The same cell line for quantification of drug potency and anti-drug neutralizing antibodies
  • Detection of functional activity of the drug/substance during Pharmacodynamics (PD) studies, as well as during manufacturing processes.
  • Unique means to reduce drug discovery attrition rates and accelerate drug development by markedly reduced selection of false positive drug leads and direct comparison of relative efficacy of drug leads between individual runs.
  • One single unique iLite cell line for lead selection, CMC potency assays/bioprocessing and immunogenicity testing for registration trials through post marketing commitments.

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.)

For the last 15 years we have developed cell-based reporter gene assays  utilizing the iLite technology for big pharma with 100% success rate.
 

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.

A typical project includes the following activities:

Development of the custom designed cell line

  • Assay development
  • Master- and working cell bank
  • Stability analysis
  • Production of assay ready frozen cells
  • CRO services (or technical assistance for the transfer)

Project timeline: 3-6 months (dependent on the complexity of the specific project).