Celerion, a Lincoln, Neb.-based provider of early clinical research, has expanded laboratory capabilities to meet growing demand for cell-based assays. Assays involving whole cells provide a variety of measures of drug activity or effect that can be important endpoints in clinical research.
Celerion has expanded this capability in response to client demand for immunogenicity assessment for large molecule analysis and for immune monitoring assays in drug development. It also supports the recently issued FDA guidance Immunogenicity Assessment for Therapeutic Protein Products.
Celerion is able to support clients’ evolving needs in immunogenicity assessment by leveraging appropriate biological models for the assessment of antidrug neutralizing antibodies. This methodology can be used to examine cell morphology, cell differentiation, cell cycle effects including apoptosis, protein regulation including modification and expression levels, and transcription activity. These assays are important biomarkers in clinical research programs of large molecule and biologically manufactured drugs including biosimilars.
Celerion’s laboratory in Nebraska is focused on flow cytometry, a powerful technique that allows the detection and measurement of different cell populations within a biological sample. The use of flow cytometry enables Celerion to develop de-novo flow cytometry assays such as cell signaling, target engagement, natural killer cell and immune function assessments.
These methods are utilized to measure therapeutic response, stratification of patient populations and the evaluation of predictive diagnostic or prognostic biomarkers in clinical research. Many of these assays require fresh samples, so being co-located within Celerion’s clinical research unit in Nebraska enables clients to leverage this technology as part of early evaluation of a new drug’s safety and pharmacological effects.
“Utilizing cell-based assay capabilities enables our clients to gain key safety data that allows them to make critical decisions for their drug development programs,” said Ray Farmen, Ph.D., vice president of global bioanalytical services at Celerion.